Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays: Feasibility Randomized Controlled Trial

Background Problems with prospective memory, which refers to the ability to remember future intentions, cause deficits in basic and instrumental activities of daily living, such as taking medications. Older adults show minimal deficits when they rely on mostly preserved and relatively automatic associative retrieval processes. On the basis of this, we propose to provide external cues to support the automatic retrieval of an intended action, that is, to take medicines. To reach this end, we developed the Medication Ambient Display (MAD), a system that unobtrusively presents relevant information (unless it requires the users’ attention) and uses different abstract modalities to provide external cues that enable older adults to easily take their medications on time and be aware of their medication adherence. Objective This study aimed to assess the adoption and effect of external cues provided through ambient displays on medication adherence in older adults. Methods A total of 16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study. We conducted a 12-week feasibility study in which we used a mixed methods approach to collect qualitative and quantitative evidence. The study included baseline, intervention, and postintervention phases. Half of the participants were randomly allocated to the treatment group (n=8), and the other half was assigned to the control group (n=8). During the study phases, research assistants measured medication adherence weekly through the pill counting technique. Results The treatment group improved their adherence behavior from 80.9% at baseline to 95.97% using the MAD in the intervention phase. This decreased to 76.71% in the postintervention phase when the MAD was no longer being used. Using a one-way repeated measures analysis of variance and a post hoc analysis using the Tukey honestly significant difference test, we identified a significant statistical difference between the preintervention and intervention phases (P=.02) and between the intervention and postintervention phases (P=.002). In addition, the medication adherence rate of the treatment group (95.97%) was greater than that of the control group (88.18%) during the intervention phase. Our qualitative results showed that the most useful cues were the auditory reminders, followed by the stylized representations of medication adherence. We also found that the MAD’s external cues not only improved older adults’ medication adherence but also mediated family caregivers’ involvement. Conclusions The findings of this study demonstrate that using ambient modalities for implementing external cues is useful for drawing the attention of older adults to remind them to take medications and to provide immediate awareness on adherence behavior. Trial Registration ClinicalTrials.gov NCT04289246; https://tinyurl.com/ufjcz97

subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

Does your paper address subitem 1a-i? *
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is the title: "Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays: Feasibility Randomized Controlled Trial". It indicates that it is as Ambient Display, which is defined in the paper's introduction using the appropriate references.

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There are no important co-interventions.

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is the title: Supporting the Medication Adherence of Older Mexican Adults .... subitem not at all important 1 2 3 4 5 essential 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Background: ..... On the basis of this, we propose to provide external cues to support the automatic retrieval of an intended action, that is, to take medicines. To reach this end, we developed the Medication Ambient Display (MAD), a system that unobtrusively presents relevant information (unless it requires the users' attention) and uses different abstract modalities to provide external cues that enable older adults to easily take their medications on time and be aware of their medication adherence.
Objective: This study aimed to assess the adoption and effect of external cues provided through ambient displays on medication adherence in older adults.
Methods: A total of 16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study. We conducted a 12-week feasibility study in which we used a mixed-methods approach to collect qualitative and quantitative evidence. The study included baseline, intervention, and postintervention phases. Half of the participants were randomly allocated to the treatment group (n=8), and the other half was assigned to the control group (n=8). During the study phases, research assistants measured medication adherence weekly through the pill counting technique." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The intervention do not required the involvement of expert providers. The participants were 16 older adults as indicated in the METHODS section of the ABSTRACT.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study .
The ABSTRACT's METHODS describe the following: "A total of 16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study. We conducted a 12-week feasibility study in which we used a mixed-methods approach to collect qualitative and quantitative evidence. The study included baseline, intervention, and postintervention phases. Half of the participants were randomly allocated to the treatment group (n=8), and the other half was assigned to the control group (n=8). During the study phases, research assistants measured medication adherence weekly through the pill counting technique." In the body text, there is additional information about how participants were recruited and the instruments used to assess the outcomes.
1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Results: The treatment group improved their adherence behavior from 80.9% at baseline to 95.97% using the MAD in the intervention phase. This decreased to 76.71% in the postintervention phase when the MAD was no longer being used. Using a one-way repeated measures analysis of variance and a post hoc analysis using the Tukey honestly significant difference test, we identified a significant statistical difference between the preintervention and intervention phases (P=.02) and between the intervention and postintervention phases (P=.002). In addition, the medication adherence rate of the treatment group (95.97%) was greater than that of the control group (88.18%) during the intervention phase. Our qualitative results showed that the most useful cues were the auditory reminders, followed by the stylized representations of medication adherence. We also found that the MAD's external cues not only improved older adults' medication adherence but also mediated family caregivers' involvement."

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Results:...... In addition, the medication adherence rate of the treatment group (95.97%) was greater than that of the control group (88.18%) during the intervention phase. .....

Conclusions:
The findings of this study demonstrate that using ambient modalities for implementing external cues is useful for drawing the attention of older adults to remind them to take medications and to provide immediate awareness on adherence behavior."

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Therefore, we propose to support external cues through a tablet-based ambient display designed to increase the retrieval process of the planned action (ie, taking medications) and to provide awareness of adherence behavior [11,12]. To reach this end, we designed the Medication Ambient Display (MAD) [12,13].
An ambient display unobtrusively presents relevant information unless it requires the users' attention [14]. In addition, users can easily monitor the display to obtain the desired information because it uses abstract modalities to represent information, such as pictures, sounds, and movement [14]. Thus, we used different abstract modalities to provide external cues that enable older adults to easily obtain relevant information to take their medications on time and be aware of their medication adherence.
........ In contrast to the previously mentioned works, our technological approach uses ambient modalities to provide external cues that aim to increase the retrieval process of the planned action and to provide daily and immediate awareness about how medication regimens are followed during the day. We assessed the effect of our approach by using objective medication adherence measures; moreover, we obtained qualitative findings that help us understand the adoption of the MAD. For this end, we provided seniors with the MAD to support the medication treatments prescribed by their physicians and the timetables that the seniors themselves proposed to follow." 2a-ii) Scientific background, rationale: What is known about the (type of) system In contrast to the previously mentioned works, our technological approach uses ambient modalities to provide external cues that aim to increase the retrieval process of the planned action and to provide daily and immediate awareness about how medication regimens are followed during the day......" Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Objectives Our study aimed to address the following research questions (RQ): RQ1: What is the effect of the external cues provided by the MAD on older adults' medication adherence? RQ2: How do the MAD design features promote its adoption?"` 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Baseline data were collected during weeks 6 to 10 on medication adherence by using the pill counting technique"......"We conducted a session with the research assistants, who made a random and blind allocation of the participants to the treatment group (TG) and the control group (CG)...." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Baseline data were collected during weeks 6 to 10 on medication adherence by using the pill counting technique. We noticed that participants accumulated containers with the same medications. Under those circumstances, we provided seniors with a basket to arrange the medications that should be taken each week (see Figure 2), which facilitated data collection for measuring the Dosage_pill adherence outcome."

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].

4a) Eligibility criteria for participants
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "To be eligible, older adults had to meet the following criteria: be older than 60 years, take at least three medications prescribed by a physician (ie, polypharmacy), have mild cognitive impairment, report medication-forgetting events, and live with a relative who could provide us with information on the assistance required by the study participant to take their medications. The exclusion criteria were as follows: being unable to self-administer medications due to a functionality problem or severe cognitive impairment, and not taking pill-based medications (it may be difficult to assess adherence otherwise). To participate in the study, it was not a requirement that older adults have experience in the use of the internet or mobile devices."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "....To participate in the study, it was not a requirement that older adults have experience in the use of the internet or mobile devices." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was conducted in Mexicali, Mexico. Ten students from the Faculty of Nursing at the Universidad Autónoma de Baja California participated as research assistants. These students were enrolled in a social service program at the Community Center of the University (known as the UNICOM), which aims to provide seniors with occupational therapy and provide some health care assistance. The UNICOM is strategically located in a neighborhood where aging inhabitants predominate. For recruiting participants, research assistants contacted older adults in the vicinity of the UNICOM and administered a set of instruments as summarized in Table 1. First, the Spanish version of the 10-item Short Portable Mental Status Questionnaire was administered....... In addition, relatives of older adults were interviewed to identify their role in helping older adults follow their medication routine. Older adults who met the eligibility criteria and expressed their interest to participate were enrolled in the study. The recruitment procedure lasted approximately 5 weeks."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Older adults who met the eligibility criteria and expressed their interest to participate were enrolled in the study......We obtained informed written consent from all individual participants." 4b) Settings and locations where the data were collected subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was conducted in Mexicali, Mexico. Ten students from the Faculty of Nursing at the Universidad Autónoma de Baja California participated as research assistants. These students were enrolled in a social service program at the Community Center of the University (known as the UNICOM), which aims to provide seniors with occupational therapy and provide some health care assistance. The UNICOM is strategically located in a neighborhood where aging inhabitants predominate.....Once the participants were recruited, we realized that they were primarily of low socioeconomic status and affiliated with the Mexican Institute of Social Security (IMSS), the largest medical institution in Mexico. Periodically (monthly or bimonthly), they attended an IMSS clinic for follow-up consultation and to retrieve an updated prescription to get their medications from the clinic's pharmacy. The lack of adequate health care and pharmaceutical policies to rationally manage medications and monitor the treatment of patients increases the vulnerability of Mexican seniors to medication errors [31], a situation that is also faced in other countries [32,33]."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise. subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not use online questionnaires, but we used questionnaires for the self-assessment of medication adherence as stated in the paper: ". Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants were informed by the research assistants that this was a project of the Autonomous University of Baja California.

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Conflicts of Interest None declared".

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Design and Implementation of the Medication Ambient Display For medical information systems to be more specific to the needs of users, an iterative approach must be followed, which consists of different usability studies [34]. In this sense, our previous work included usability studies that helped us inform the design of the MAD. They included (1) a usability inspection in which experts (usability engineers and geriatricians) determined how the MAD conformed to usability design principles for ambient displays [11] and (2) a field evaluation to identify technical and usability problems that we addressed without altering the conceptual design of the MAD [12,13]. In this paper, we present the trial study that we conducted to evaluate the effect of the MAD on measures of adherence to medication and its possible adoption......."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.
Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The intervention did not have major changes during the evaluation process.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We do not follow any specific quality assurance method.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting. Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We provided screen-shots of the system's user interfaces, and the system's functionality is explained based on how its interfaces enable users to access their medication information.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We published in this paper the screen shots of the system's user interfaces.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

Does your paper address subitem 5-vii? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We provided participants with a Tablet PC which was withdrawn at the end of the study as stated in the paper: "We implemented the MAD for Android tablets to be placed as portrait frames in the older adults' homes......The ethics review board of Faculty of Nursing approved the study protocol once we proposed how to address their suggestions on how to handle the withdrawal of the technology at the study end. We agreed to provide the participants of the TG with an adequate financial incentive that would allow them (if desired) to obtain a PC tablet similar to the one used during the study. Every week, participants received an economic incentive, approximately US $7 if they were in the CG and US $14 if they were in the TG. We obtained informed written consent from all individual participants." Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This item is addressed in the Introduction and Methods sections.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum. Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Table 2 describes the outcome variables and methods used to collect data to address research question.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Research assistants conducted the data collection during as stated in the paper: "Ten students from the Faculty of Nursing at the Universidad Autónoma de Baja California participated as research assistants. These students were enrolled in a social service program at the Community Center of the University (known as the UNICOM), which aims to provide seniors with occupational therapy and provide some health care assistance...." Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not provided any reminder to use the system.

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 33/62 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "On the first day of this phase, research assistants visited older adults in the TG to introduce the MAD in the presence of caregivers by using the spaced retrieval approach, that is, teach, ask, wait, ask again, wait, and ask again [35]....." Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Table 2 Describes the outcome variables and methods used to collect data to assess them. We explain the methods used to Analyze the outcomes in the Data Analysis section: "We used Student t tests and chi-square tests to measure the statistical difference in age, the number of prescribed medicines, and self-reported medication adherence between the TG and the CG. A one-way repeated measure analysis of variance (ANOVA), dependent t tests, and independent t tests were used to find significant differences in medication adherence between the study phases and between the TG and the CG. The McNemar test was used to verify differences within the TG between the self-reported medication adherence in the recruitment and intervention phases. To determine whether any of the differences between the means estimated are statistically significant, we compared the P value with a significance level set to . 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "During the intervention phase, we also collected qualitative evidence about the system's adoption, which enabled us to address RQ2. We interviewed the older adults in the TG regarding the system's functionalities that they perceived as most useful, less useful, and the difficulties faced while using it. At the end of the post-intervention stage, we interviewed participants to obtain their perceptions of how withdrawal from the MAD impacted their medication adherence. In addition, those caregivers who were at home during our visits were interviewed to obtain information on their involvement in the seniors' medication activities. Our questions centered on the specific activities associated with the older adult's medication regimen that caregivers were involved in and how they knew if the older adult took his or her pills in a given week. These semistructured interviews were administered by the first 3 authors of this paper......For the qualitative analysis, we transcribed the collected data from their original Spanish version, that is, audio, handwritten notes, and photographs taken during the interviews. Individual quotes were translated into English for use in this paper. We followed the thematic analysis approach, which consists of generating initial codes from the data, searching for potential themes, contrasting the identified themes with the data, and iteratively refining them [36]." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "During the intervention phase, we also collected qualitative evidence about the system's adoption, which enabled us to address RQ2. We interviewed the older adults in the TG regarding the system's functionalities that they perceived as most useful, less useful, and the difficulties faced while using it. At the end of the post-intervention stage, we interviewed participants to obtain their perceptions of how withdrawal from the MAD impacted their medication adherence. In addition, those caregivers who were at home during our visits were interviewed to obtain information on their involvement in the seniors' medication activities." Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Baseline data were collected during weeks 6 to 10 on medication adherence by using the pill counting technique. We noticed that participants accumulated containers with the same medications. Under those circumstances, we provided seniors with a basket to arrange the medications that should be taken each week (see Figure 2), which facilitated data collection for measuring the Dosagepill adherence outcome (see Table 2)." subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study As it is a feasibility study, we determined the sample size based on the resources that we had for providing them with Tablets PC and economic incentives for enabling to access data.
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We do not used and interim analysis and stopping guidelines.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 38/62 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We conducted a session with the research assistants, who made a random and blind allocation of the participants to the treatment group (TG) and the control group (CG)." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We conducted a session with the research assistants, who made a random and blind allocation of the participants to the treatment group (TG) and the control group (CG)." Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We conducted a session with the research assistants, who made a random and blind allocation of the participants to the treatment group (TG) and the control group (CG)." Ten research assistants participated in this session. Each of the assistants blindly selected a participant number from a tray. Then they placed the selected number in one of the other two trays corresponding to TG and CG.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We conducted a session with the research assistants, who made a random and blind allocation of the participants to the treatment group (TG) and the control group (CG)."

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

Does your paper address subitem 11a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not address this item. 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants were informed about the interventions to use since they were recruited and signed the informed consent to accept using any of the interventions.
Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study It is not relevant.
12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We used Student t tests and chi-square tests to measure the statistical difference in age, the number of prescribed medicines, and self-reported medication adherence between the TG and the CG. A one-way repeated measure analysis of variance (ANOVA), dependent t tests, and independent t tests were used to find significant differences in medication adherence between the study phases and between the TG and the CG. The McNemar test was used to verify differences within the TG between the self-reported medication adherence in the recruitment and intervention phases. To determine whether any of the differences between the means estimated are statistically significant, we compared the P value with a significance level set to .05 [35]."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "They identified 42 potential participants; 20 of them met the eligibility criteria and were enrolled in the study. However, only 16 completed the study. The analysis of baseline data presented in Table 3 indicated that the TG and the CG had no significant differences in age (P=.21), number of medicines taken (P=.33), self-reported medication adherence (P=.59), education in years (P=.35), gender (P=.25), relationship with caregiver (P=.57), and dosage outcome (P=.77)." For the data analysis, we used the data collected from the 16 participants that completed the study.
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not conducted additional analysis. Does your paper address subitem X26-i?

X26-i) Comment on ethics committee approval
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The ethics review board of Faculty of Nursing approved the study protocol once we proposed how to address their suggestions on how to handle the withdrawal of the technology at the study end. We agreed to provide the participants of the TG with an adequate financial incentive that would allow them (if desired) to obtain a PC tablet similar to the one used during the study...."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We obtained informed written consent from all individual participants."

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "On the first day of this phase, research assistants visited older adults in the TG to introduce the MAD in the presence of caregivers by using the spaced retrieval approach, that is, teach, ask, wait, ask again, wait, and ask again [35]. This approach has been used to support the encoding, retention, and retrieval processes involved in interventions designed to assist medication taking [35]. Thus, we explained to participants how to carry out medication taking using the system. Afterward, we asked them to recall the system features we had just presented and assisted them as necessary. To do this, we activated each of the system's functionalities and asked participants to use them (eg, interpreting a reminder, registering a medication, and consulting and interpreting their medication compliance). Then, we waited for 1 min and asked them to recall the system's functionalities again. We asked them again 15 min later and repeated it once again." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 45/62 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The research assistants contacted approximately 100 older adults to participate in the study (see Figure 8). They identified 42 potential participants; 20 of them met the eligibility criteria and were enrolled in the study. However, only 16 completed the study........ On the first day of this phase, research assistants visited older adults in the TG to introduce the MAD in the presence of caregivers......The TG improved their adherence behavior (dosage), increasing from 80.9% in the preintervention phase to 95.97% in the intervention phase. However, it decreased to 76.71% in the postintervention phase. Using a one-way repeated measures ANOVA, we compared the effect of the MAD in the TG during the 3 phases......The medication adherence rate of the TG (mean 95.97% [SD 6.08%]) was higher than that of the CG (mean 88.18% [SD 13.06%]) during the intervention phase. ." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Figure 8 shows a flow diagram of the participants' progress through the study phases.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See figure of Appendix 1. "......Multimedia Appendix 1 shows that participant P2 has adherence rates higher than 100% according to both techniques. Similarly, overmedication could be present in the baseline data, which impacted the high medication rates registered for some older adults (eg, participants P7 and P8). However, our results show that the introduction of the MAD's external cues to the TG resulted in significant improvements in the average rates of dosage outcomes, which addresses RQ1." Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The evaluation of the MAD was designed as a small trial study. This section presents the study timeline, the activities conducted, and the instruments used to collect data (see Figure  1)." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The item is not applicable/relevant since there were no critical "secular events".
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study It is not applicable. subitem not at all important 1 2 3 4 5 essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Table 3.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See table 3 which shows demographics such as gender, education and age. We also reported the following: "Once the participants were recruited, we realized that they were primarily of low socioeconomic status and affiliated with the Mexican Institute of Social Security (IMSS), the largest medical institution in Mexico.......The analysis of baseline data presented in Table 3  16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All older adults, except participant P4, reported that they did not consult the detailed information on their medication adherence, but they verified if the parakeet grew after registering the medication as taken......Participant P6 was the only participant who, during the interviews, admitted forgetting to take her medication because as a consequence... "

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Dosagepill (Treatment Group) The TG improved their adherence behavior (dosage), increasing from 80.9% in the preintervention phase to 95.97% in the intervention phase. However, it decreased to 76.71% in the postintervention phase. Using a one-way repeated measures ANOVA, we compared the effect of the MAD in the TG during the 3 phases. It showed a significant statistical difference between at least two of the phases (F2,14=6.59; P=.0096). With a post hoc analysis using the Tukey honestly significant difference test, we identified a statistical difference between the preintervention and intervention phases (P=.02) and between the intervention and postintervention phases (P=.002); Cohen effect size values (d=1.35 and d=1.72, respectively) suggest a high practical significance in both cases. In addition, there was no statistical difference between the preintervention and the postintervention phases (P=.73). Therefore, these results are evidence that the external cues of the MAD contributed to improving the medication intake behaviors of older adults. subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study In Table 2, it is indicated the following: " [Timely outcome] It indicates whether the medication was taken 30 min before or after the time expected to take the medication. This is the number of medication episodes registered in the time window during a period divided by the number of episodes registered as taken for that period" In the text, it is explained: ..........We obtained 2224 medication episodes registered in the MAD's log, of which 93.17% (2072/2224) were registered as taken on time, and 88.35% (1830/2224) of these timely episodes were taken after the MAD reminders. As illustrated in Table 4, most of the participants showed a high reminder dependency rate. These results are evidence that the MAD reminders resulted in medication-taking behaviors consistently." 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No applicable.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No applicable.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See the Limitations sections: "Although using our technology did not introduce any risk, it might have supported inappropriate medication routines adopted by older adults to overcome some of the barriers imposed by the setting. We recognize the importance of conducting a contextual study before conducting a technology evaluation. The contextual study should be designed in collaboration with clinical or nursing specialists to reduce the complexity of older adults' medication regimens and the risks associated with the way they manage medications. "

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

DISCUSSION
Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Although using our technology did not introduce any risk, it might have supported inappropriate medication routines adopted by older adults to overcome some of the barriers imposed by the setting. We recognize the importance of conducting a contextual study before conducting a technology evaluation. The contextual study should be designed in collaboration with clinical or nursing specialists to reduce the complexity of older adults' medication regimens and the risks associated with the way they manage medications. "

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "...we obtained qualitative findings that explained the adoption of the MAD from the perspectives of both seniors and their relatives. Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

Does your paper address subitem 22-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "System Adoption (Research Question 2) The collected qualitative evidence helps us to address RQ2 and to complement the quantitative results. We analyzed the data collected from the interviews administered to participants P1  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "......For future work, we plan to conduct studies to assess the feasibility of external ambient cues to support the seamless integration of medication regimens into the daily routines of the elderly....."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Limitations section: "Economic Incentive for Participating The use of financial incentives has been questioned because they may provide inducements to participate in a study for financial purposes only, and vulnerable populations are prone to be enticed by the financial reward and be more willing to accept any study risks [38]. In our opinion, offering an incentive facilitated recruitment of participants and allowed us to access their data, which would otherwise be considered an obtrusive task. For instance, 2 participants explicitly asked for the weekly economic incentive to allow the research assistants to collect data; another participant questioned the incentive since she considered it was unnecessary for being part of the study. Although we are not able to conclude on how the incentive impacted the adoption of the technology, our findings indicate that the MAD was accepted not only by older adults but also by their family caregivers.

Setting Characteristics
We observed that some participants faced problems in managing their medications, such as accumulating medications, confusing medications because they look alike, and tending to give medications to others, which may not be an appropriate practice. The design of our study was limited in that the MAD system was personalized according to the prescribed medication regimens and timetables that the participants followed. .........."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations

23) Registration number and name of trial registry
Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study ".... Finally, we are not able to state that our results are generalizable to the whole Mexican elderly population. This is because participants were primarily from a low-income socioeconomic stratum; therefore, exploring this technology among high-income elders who have access to private health care services might produce different findings......"

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This item are addressed in the Introduction and Discussion sections. Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No trial registry of this feasibility study.
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Ten students from the Faculty of Nursing at the Universidad Autónoma de Baja California participated as research assistants. These students were enrolled in a social service program at the Community Center of the University (known as the UNICOM), which aims to provide seniors with occupational therapy and provide some health care assistance....
During the study phases, research assistants measured medication adherence weekly through the pill counting technique....." As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?

Tu respuesta
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

hours
As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document