Web-Based Intervention for Family Carers of Persons with Dementia and Multiple Chronic Conditions (My Tools 4 Care): Pragmatic Randomized Controlled Trial

Background My Tools 4 Care (MT4C) is a Web-based intervention that was developed based on the transitions theory. It is an interactive, self-administered, and portable toolkit containing six main sections intended to support carers of community-living persons with Alzheimer’s disease and related dementia and multiple chronic conditions through their transition experiences. Objective The objective of our study was to evaluate the effectiveness of MT4C with respect to increasing hope, self-efficacy, and health-related quality of life in carers of community-living older persons with Alzheimer’s disease and related dementia and multiple chronic conditions. Methods A multisite, pragmatic, mixed methods, longitudinal, repeated-measures, randomized controlled trial was conducted between June 2015 and April 2017. Eligible participants were randomized into either treatment (MT4C) or educational control groups. Following baseline measures, carers in the treatment group received 3 months of password-protected access to MT4C. Trained research assistants collected data from participants via phone on hope (Herth Hope Index [HHI]), self-efficacy (General Self-Efficacy Scale), and health-related quality of life (Short Form-12 item [version 2] health survey; SF-12v2) at baseline, 1, 3, and 6 months. The use and cost of health and social services (Health and Social Services Utilization Inventory) among participants were measured at baseline, 3, and 6 months. Analysis of covariance was used to identify group differences at 3 months, and generalized estimating equations were used to identify group differences over time. Results A total of 199 carers participated in this study, with 101 participants in the treatment group and 98 in the educational control group. Of all, 23% (45/199) participants withdrew during the study for various reasons, including institutionalization or death of the person with dementia and lack of time from the carer. In the treatment group, 73% (74/101) carers used MT4C at least once over the 3-month period. No significant differences in the primary outcome measure (mental component summary score from the SF-12v2) by group or time were noted at 3 months; however, significant differences were evident for HHI-factor 2 (P=.01), with higher hope scores in the treatment group than in the control group. General estimating equations showed no statistically significant group differences in terms of mental component summary score at all time points. Attrition and the fact that not all carers in the treatment group used MT4C may explain the absence of statistically significant results for the main outcome variable. Conclusions Despite no significant differences between groups in terms of the primary outcome variable (mental component score), the significant differences in terms of one of the hope factors suggest that MT4C had a positive influence on the lives of participants. Trial Registration ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387 (Archived by Webcite at http://www.webcitation.org/708oFCR8h).

yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * Access to MT4C was granted for 3 months, after that time participants Overall, was the app/intervention effective? * Participants in the treatment group had statistically higher scores than t TITLE AND ABSTRACT 1a) TITLE: Identi cation as a randomized trial in the title yes Other: subitem not at all important 1 2 3 4 5 essential Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 10484 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") 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 o ine 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.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study Yes, this item is part of the title "A Randomized Pragmatic Control Trial of A Webbased Intervention (My Tools 4 Care)...." 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").
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 brie y explain why the item is not applicable/relevant for your study Not applicable, Intervention was web-based and there was no other component to it.
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 brie y explain why the item is not applicable/relevant for your study Yes, title outlines that target group was " Family Carers of Persons with Dementia and Multiple Chronic Conditions." 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
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 brie y explain why the item is not applicable/relevant for your study "My Tools 4 Care (MT4C) is a web-based intervention developed based on transitions theory" "It is an interactive, self-administered, and portable toolkit containing six main sections intended to support carers of community-living persons with Alzheimer Disease and related dementia (ADRD) and multiple chronic conditions (MCC) through their transition experiences. " "Eligible participants were randomized into either treatment (MT4C) or educational control groups. Following baseline measures, carers in the treatment group received 3 months of password-protected access to MT4C." "A total of 199 carers participated in the study (Ontario n = 106, Alberta n = 93). In the treatment group there were 101 participants and 98 were in the educational control group" 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 brie y explain why the item is not applicable/relevant for your study This section is not applicable as the intervention was self administered by participants (carers) 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), 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 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 brie y explain why the item is not applicable/relevant for your study "Following baseline measures, carers in the treatment group received 3 months of password-protected access to MT4C." "Quantitative data on hope (Herth Hope Index) self-e cacy (General Self E cacy Scale), and HRQOL (SF12v2) were collected by a trained research assistant over the telephone at baseline, 1, 3, and 6 months." 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) 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 brie y explain why the item is not applicable/relevant for your study "A total of 199 carers participated in the study (Ontario n = 106, Alberta n = 93). In the treatment group there were 101 participants and 98 were in the educational control group." "Forty-ve out of 199 participants ( "Three systematic reviews of web-based interventions for carers of persons with ADRD [2,8,9] reported that interventions resulting in improved carer health outcomes, e.g., reduced anxiety and stress, were those that: a) could be individually tailored by incorporating choice to different parts of the intervention [10-12]; b) offered multiple components [10,13,14]; and c) were psycho-educational interventions [10,12,[15][16][17][18][19][20]. Most of the studies reviewed were pilot studies with the authors recommending future research is needed using pragmatic randomized control trials designs to evaluate web-based interventions. As well, when articulated, the most common theoretical foundation for the interventions was stress and burden theories with a focus on strain and depression [21]. However, these theories do not address the multiple, complex , re-occurring signi cant life-altering changes and processes of change ( METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 brie y explain why the item is not applicable/relevant for your study "The purpose of this pragmatic randomized control trial (RCT) was to evaluate the effectiveness of MT4C with respect to increasing health related quality of life (HRQOL), self-e cacy, and hope of carers of older adults with ADRD and MCCs in the community. Participants in the treatment group used MT4C for 3 months. We hypothesized that participants using MT4C would have higher hope, general selfcacy, and HRQOL scores at 3 months in comparison to both baseline and an educational control group, at no additional cost." 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 brie y explain why the item is not applicable/relevant for your study "The study design was a multi-site, pragmatic, mixed methods, longitudinal, repeated measures, randomized controlled trial." "Allocation of participants into treatment and educational control groups was achieved using a 1:1 ratio. A biostatistician not involved in recruitment generated group allocations using strati ed permuted block randomization. Random number sequences were input into RedCap, a secure, password-protected web-based randomization service offered at the University of Alberta that allocated clients to the two groups according to the sequence" subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 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 brie y explain why the item is not applicable/relevant for your study Not applicable as there were no changes to methods after trial commencement 3b-i) Bug xes, Downtimes, Content Changes Bug xes, 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 xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
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 brie y explain why the item is not applicable/relevant for your study "There were no changes to the content of MT4C, bug xes, or unexpected events in using MT4C during this study." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Participants were considered eligible to participate in the study if they were over the age of 18 years and were providing physical, emotional, or nancial care for a care recipient who was 65 years of age or older with ADRD and two or more chronic conditions living in the community. They were English speaking and either a family or friend of the care recipient, with access to a computer and a valid e-mail address. Exclusion criteria were non-English speaking, and caring for a family member or friend who as under the age of 65, did not have ADRD and MCC and was not living in the community."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
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 brie y explain why the item is not applicable/relevant for your study "family or friend of the care recipient, with access to a computer and a valid e-mail address." 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. o ine), e.g., from an open access website or from a clinic, 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), 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 con rmation, 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 brie y explain why the item is not applicable/relevant for your study "Participant recruitment occurred o ine over a two-year time period in two Canadian provinces (Ontario and Alberta) using multiple strategies. In the local branches of the Alzheimer's Society, in both provinces, trained research assistants attended education groups for carers and shared information on the study, including its purpose and inclusion criteria. In addition, staff at the Alzheimer's Society and coordinators at community-based carer support groups, geriatric outpatient or memory clinics, adult day programs, and senior support services were provided with recruitment materials (e.g., brochures or postcards). Staff members from these groups approached potential participants and obtained their consent to be contacted by the research team. In Alberta, advertisements in local community newspapers asked interested carers to contact the research coordinator using a tollfree number or email." "Research assistants contacted interested carers over the phone to screen for eligibility and schedule the rst interview." "Given the nature of the study, the research team was not blinded for group allocation. Recruitment materials referred to evaluating different strategies to help carers, and did not mention MT4C. As well to prevent contamination, participants were asked to keep information about what group they were in con dential. To prevent participants from identifying the group to which they were allocated, two different consent forms were created, one for each group. These were used to obtain verbal telephone informed consent from each study participant. The consent form also acknowledged potential risks that participants might encounter during the study (see appendix A). Immediately following the rst interview, participants received an email from the research assistant containing information on the study along with copies of the consent form and data collection tools." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 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 brie y explain why the item is not applicable/relevant for your study "Recruitment materials referred to evaluating different strategies to help carers, and did not mention MT4C. As well to prevent contamination, participants were asked to keep information about what group they were in con dential." Consent forms are attached in Appendix A.
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 brie y explain why the item is not applicable/relevant for your study Yes, throughout the methods the manuscript states that data collection took place in Alberta and Ontario. This was collected by research assistants in each province via telephone through the use of questionnaires (quantitative data) and interview guides (qualitative data).
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
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 brie y explain why the item is not applicable/relevant for your study "Trained research assistants, in each province, completed interviews (quantitative and qualitative) took place over the phone, were audio recorded, and lasted anywhere from 15 to 60 minutes." 4b-ii) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 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 brie y explain why the item is not applicable/relevant for your study This was not included in the manuscript. However potential participants were made aware during recruitment that the University of Alberta and McMaster University were conducting the study.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, a liations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
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 brie y explain why the item is not applicable/relevant for your study Not applicable. Authors/Evaluators did not develop any software.

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.
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 brie y explain why the item is not applicable/relevant for your study

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 brie y explain why the item is not applicable/relevant for your study "There were no changes to the content of MT4C, bug xes, or unexpected events in using MT4C during this study."

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 brie y explain why the item is not applicable/relevant for your study "Quality of the data was checked throughout the study by research assistants and at monthly meetings by the research team." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c 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 brie y explain why the item is not applicable/relevant for your study screen shots of MT4C have been added as a multimedia appendix.

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 brie y explain why the item is not applicable/relevant for your study a link to MT4C is available in the manuscript, as well screen shots have been added in a supplemental le, as a multimedia appendix.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 speci c 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 brie y explain why the item is not applicable/relevant for your study "Participants in the treatment group were instructed to access MT4C at their convenience on a computer, tablet, or smart phone for three months." "Participants allocated to the treatment group were provided with password protected access to MT4C (at no cost)." 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "As part of the development of MT4C Duggleby et al. 's [22] adaptation of Meilies' transition theory, the core concepts of acknowledging the situation, connecting and rede ning normal were mapped to speci c components of MT4C (for more information see Duggleby et al. [24].)" "The principles that guided the development of the web-based MT4C (Figure 1) intervention were a) inclusion of choice (the carers choose which sections they would like to use and when); b) encouragement of user-generated content (carers can write in sections, add stories, pictures, music, etc.); c) portability (available on the web, tablet, or smartphone); and d) privacy of information (only the carer views their entry and has the ability to share the contents)." "Once the carer logged on to the site, the rst page (How to use MT4C; Figure 1) provided instructions on how to use MT4C and contained a menu outlining the sections that comprise the toolkit. MT4C consists of six main sections: 1) about me; 2) common changes to expect; 3) frequently asked questions; 4) resources; 5) important health information; and 6) calendar. In the About Me section, participants have the option to add formatted text, pictures, and PDF les"

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use 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 brie y explain why the item is not applicable/relevant for your study "Participants in the treatment group were instructed to access MT4C at their convenience on a computer, tablet, or smart phone for three months"

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 brie y explain why the item is not applicable/relevant for your study "Not applicable. MT4C was a self-administered intervention for carer participants. No additional assistance or intervention was used." 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed 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 brie y explain why the item is not applicable/relevant for your study "At the 1-month interview, participants were reminded that their access to MT4C would end at 3-months and were encouraged to use the site, if not done so already, and continue completing the checklist." 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 standalone 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. 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 brie y explain why the item is not applicable/relevant for your study Not applicable. No training was needed to used MT4C.
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 brie y explain why the item is not applicable/relevant for your study "All participants completed the SF12v2 at all time points. It is a widely used measure of HRQOL consisting of 12 questions, measuring eight domains of functioning and well-being (physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, emotional health, and mental health) [23,2428,29]. Overall scores are summarized in two domains: a physical component summary score (PCS) and a mental component summary score (MCS). Scores range from 0 to 100 with higher scores indicating better HRQOL. The SF-12v2 is a reliable tool with estimated PCS and MCS test-retest reliability of r = 0.89 and r = 0.86, respectively [30]. MCS was selected as the primary outcome for this study, given the psycho-educational nature of the intervention." "Secondary outcome measures included the SF-12v2 PCS score (described above) and two others: the GSES and HHI. Participants completed the GSES and HHI at all data collection time points. The GSES was used to assess a person's perceived selfe cacy or belief that they can complete novel or di cult tasks or cope with diversity [31]. It is a 10-item, 4-point scale with a Cronbach's alpha coe cient of reliability r ranging from 0.76 to 0.90 (P<0.05). Total scores range from 10 to 40 with higher scores indicating a greater level of self-e cacy. The GSES has been used in countries around the world and has been adapted to 26 languages [31]. The HHI is a 12-item Likert-type scale [32]. Items are scored from 1 "strongly disagree" to 4 "strongly agree". Total scores range from 12 to 48 with higher scores indicating greater hope. The items in the scale can be grouped into three factors of hope: 1) temporality and future, 2) positive readiness and expectancy, and 3) interconnectedness. The HHI has been used in a variety of populations and has a test-retest reliability of 0.91 (P<0.05) and criterion related validity r of 0 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "Participants accessing MT4C were asked to document, o ine, the frequency and amount of time (in minutes) they spent on each section of the MT4C site. Research assistants reviewed this information with participants at the 1-and 3-month interviews." subitem not at all important 1 2 3 4 5 essential 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 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).
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "At 3 and 6 months, participants using MT4C were asked about: a) their perceptions of MT4C, b) how MT4C helped them deal with transitions, c) what they like most and least about MT4C, and d) changes they would make to MT4C." 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 brie y explain why the item is not applicable/relevant for your study Not applicable, there were no changes to the outcome of the study.
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 brie y explain why the item is not applicable/relevant for your study This was not included in the current manuscript as it was reported in the protocol paper.
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 brie y explain why the item is not applicable/relevant for your study not applicable.
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 brie y explain why the item is not applicable/relevant for your study "Allocation of participants into treatment and educational control groups was achieved using a 1:1 ratio." 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 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 brie y explain why the item is not applicable/relevant for your study "A biostatistician not involved in recruitment generated group allocations using strati ed permuted block randomization." 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 brie y explain why the item is not applicable/relevant for your study "Random number sequences were input into RedCap, a secure, password-protected web-based randomization service offered at the University of Alberta that allocated clients to the two groups according to the sequence" 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 brie y explain why the item is not applicable/relevant for your study "A biostatistician not involved in recruitment generated group allocations" 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 subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Given the nature of the study, the research team was not blinded for group allocation. To prevent participants from identifying the group to which they were allocated, two different consent forms were created, one for each group." 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".
11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 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 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 brie y explain why the item is not applicable/relevant for your study "Recruitment materials referred to evaluating different strategies to help carers, and did not mention MT4C. As well to prevent contamination, participants were asked to keep information about what group they were in con dential" 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 brie y explain why the item is not applicable/relevant for your study Not applicable, the study did not involve placebos.
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 brie y explain why the item is not applicable/relevant for your study "Statistical tests assumed a 0.05 two-tailed level of signi cance and 95% con dence intervals. Baseline characteristics data are presented as means and standard deviations for continuous variables, and numbers and percentages for categorical variables. Analysis of covariance (ANCOVA) was used to test the differences in outcome variables between the intervention and control groups at 3 months. The 3month analysis represents the primary analysis for this study, because this period corresponds to the duration of the intervention. Separate ANCOVA models were run for each outcome, with the 3-month outcome as the dependent variable, group (intervention, control) as the independent variable, and baseline value of the outcome as the covariate. Intention-to-treat principles were used in the analysis, and thus all participant data were analyzed in the groups in which they were originally allocated (including those in the treatment group who did not utilize MT4C)" "Cost analyses were conducted to compare the cost of health service use of the intervention and control groups...Cost data are substantially positively skewed and have traditionally been handled using non-parametric methods [40]. A Mann-Whitney U-test was used to evaluate group differences in median costs and to compare total service costs at baseline and 3 months for the two groups." 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]).

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
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 brie y explain why the item is not applicable/relevant for your study "imputation was applied to address missing data. Multiple imputation is considered the best method for addressing the most common and realistic missing data patterns seen in RCTs [37]. We performed multiple imputation using the general procedure and employing the fully conditional speci cation procedure with predictor mean matching [38]. A range of auxiliary and outcome variables were used in the imputation model to improve accuracy, and thus the imputation model included baseline variables (caregiver age, gender, number of carer chronic conditions, and number of care recipient chronic conditions) as well as the secondary outcome variables. After missing data were imputed ( ve imputations), each data set was analyzed using ANCOVA, and the results from these multiple analyses pooled to obtain an overall inference. Sensitivity analyses were performed using the complete case data set."

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Subgroup analyses were performed to determine whether differences in intervention effectiveness for the primary outcome were observed for speci c baseline groups and were restricted to the following six baseline factors: age, gender, carer employment status, number of carer chronic conditions, number of care recipient chronic conditions, and income. Subgroup differences in the intervention effect were determined based on signi cance of the group or subgroup interaction term in the ANCOVA model. Generalized estimating equations (GEE) were used to determine any group differences over the 6-month period. GEE was selected because it is a robust method that does not rely on normality assumptions to address the dependency in repeated-measures data [39]. This 6-month analysis is regarded as a secondary/supplemental analysis in this study, because the 3-to 6month period corresponds to when the intervention was no longer available to treatment group participants. Separate GEE models were run for each outcome (primary, secondary 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 brie y explain why the item is not applicable/relevant for your study "The study received ethical approval from the University of Alberta Health Research Ethics Board (# Pro0004872) and the Hamilton Integrated Research Ethics Board (#15-309)."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine 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 brie y explain why the item is not applicable/relevant for your study "To prevent participants from identifying the group to which they were allocated, two different consent forms were created, one for each group...These were used to obtain verbal telephone informed consent from each study participant." Consent forms have been attached as an Appendix (appendix A)

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)

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 13b) For each group, losses and exclusions after randomisation, together with reasons 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 brie y explain why the item is not applicable/relevant for your study "All data entered by participants into the site remained con dential, even from the study team" 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 brie y explain why the item is not applicable/relevant for your study "Participants were randomly assigned into treatment (n = 101) or control (n = 98) groups. Forty-ve out of 199 participants (22.6%) withdrew during the study ( Figure  3). A total of 154 carers completed the study (treatment n = 73; control n = 81)" "Out of the 101 carers randomized into the intervention group, 74 (73.3%) used the MT4C toolkit at least once over the 3-month period" subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow 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 brie y explain why the item is not applicable/relevant for your study Refer to withdrawal diagram in supplemental multimedia appendix 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 gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study not applicable.
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 brie y explain why the item is not applicable/relevant for your study " Recruitment began on May 2015, a total of 382 persons were contacted, resulting in 199 carers of persons with ADRD and MCC residing in the community who participated in the study (Ontario n = 106 and Alberta n = 93)" subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant 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 brie y explain why the item is not applicable/relevant for your study not applicable, there were no secular events during the study period.
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 brie y explain why the item is not applicable/relevant for your study Not applicable, trial ended at anticipated time.
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 brie y explain why the item is not applicable/relevant for your study See 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 brie y explain why the item is not applicable/relevant for your study "Randomization resulted in no signi cant differences between the two groups (control vs. intervention)" 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: 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 speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) 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 brie y explain why the item is not applicable/relevant for your study "Out of the 101 carers randomized into the intervention group, 74 (73%) used the MT4C toolkit at least once over the 3 month period. At 1 month, participants who used the site spent the most time on Section 1 My story (median = 9.5 min, interquartile range (IQR) = 28.4). By 3 months, participants spent most of their time on Section 2 Common changes to expect (median = 15 min, IQR = 45.0) and Section 4 Resources (median=10.00 min, IQR = 20.0)." Where applicable N values are present throughout in the text, gures, and tables.

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).
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 brie y explain why the item is not applicable/relevant for your study Yes primary analysis involved intend to treat. See data analysis section.
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 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 brie y explain why the item is not applicable/relevant for your study "Statistical tests assumed a 0.05 two-tailed level of signi cance and 95% con dence intervals. " 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 de nitions 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 de ned (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 brie y explain why the item is not applicable/relevant for your study not applicable.
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 brie y explain why the item is not applicable/relevant for your study not 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 brie y explain why the item is not applicable/relevant for your study "Intention-to-treat principles were used in the analysis, and thus all participant data were analyzed in the groups in which they were originally allocated (including those in the treatment group who did not utilize MT4C)"

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).
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 brie y explain why the item is not applicable/relevant for your study "Subgroup analyses were performed to determine whether differences in intervention effectiveness for the primary outcome were observed for speci c baseline groups and were restricted to the following six baseline factors: age, gender, carer employment status, number of carer chronic conditions, number of care recipient chronic conditions, and income. Subgroup differences in the intervention effect were determined based on signi cance of the group or subgroup interaction term in the ANCOVA model" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "All data entered by participants into the site remained con dential, even from the study team." "The consent form also acknowledged potential risks that participants might encounter during the study (see appendix A)" Appendix A contains copies of the consent forms which outline the potential risks of the study under the subheading: Potential Risks

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].
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 brie y explain why the item is not applicable/relevant for your study Not applicable as there were no privacy breaches or technical problems. 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 brie y explain why the item is not applicable/relevant for your study This paper reports mostly on the quantitative ndings of the study, qualitative data was integrated at the results stage to support quantitative ndings.
"Participants who felt MT4C did not help them with transitions suggested it was because they were already privy to su cient resources. For example, one participant noted that MT4C "didn't help me signi cantly... I had gone to some carers' group and got some information there".
22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "The purpose of this study was to examine the in uence of using a selfadministered, multi-component, web-based intervention (MT4C) in increasing hope, general self-e cacy, and mental health compared to an educational control group. Despite no signi cant differences between the treatment (MT4C) and the educational control group for the primary or secondary outcome measures, the treatment group had signi cantly higher factor 2 hope scores than the control group at 3 months. Factor 2 on the HHI is a subscale entitled "positive readiness and expectancy" and re ects the con dence of the person in their ability to have a positive future [32]. Statements in this subscale include feeling that "there is a light at the end of the tunnel" and "I have a direction". This increase in hope, is consistent with our adapted transition theory which suggests when carers are able to rede ne what they perceive as normal, they report increases in hope." 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 brie y explain why the item is not applicable/relevant for your study "Other web-based interventions for family carers that report statistically signi cant ndings focus on outcomes such as anxiety, distress, and depression [1]. Other aspects of mental health and quality of life might have been more sensitive to a treatment effect as a result of using MT4C. A review of multi-component interventions for family carers of people with dementia suggests changing quality of life through interventions is di cult because quality of life can quickly deteriorate in carers of persons with dementia [44]. Future evaluation of MT4C should target more speci c outcomes, such as anxiety, distress, and depression." "Hope and general self-e cacy, as signi cant variables in uencing mental health, suggest that the model for the intervention has promise, and that those activities within MT4C targeted at increasing hope and general self-e cacy should be strengthened. " "Future research should incorporate measurement of time spent on which components into the web design. "

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. 21) Generalisability (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial 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 brie y explain why the item is not applicable/relevant for your study "This study has several limitations. Attrition over time resulted in 166 participants at 3 months (post intervention), which is below the sample size required to determine signi cance. Although multiple strategies were used, similar to other research, recruiting carers for participating in research was di cult. In addition, since this was a convenience sample, the generalizability is limited. Future research on MT4C should be conducted with larger sample sizes, and include a more random sampling approach. The participants were well educated and had access to computers; however, 26.7% of the treatment group did not use MT4C in the 3-month period. Non-use of web-based interventions has been reported in other studies [45]. Another limitation is that the majority of participants were recruited from Alzheimer's Societies and already had access to resources. As well there is the possibility, even with blinding of the consents, that there was contamination as the treatment group participants may have discussed MT4C with the control group participants. Future research should examine whether users of MT4C who are unable to attend Alzheimer Society support groups would achieve signi cant improvements in their mental health. Finally, the limitation regarding participant use of MT4C is of concern.
In future research, participants should be instructed more clearly regarding the importance of utilizing MT4C and potentially speci c components within; moreover, keeping track of the time spent can be accomplished through website design strategies." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 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 brie y explain why the item is not applicable/relevant for your study "This study has several limitations. Attrition over time resulted in 166 participants at 3 months (post intervention), which is below the sample size required to determine signi cance. Although multiple strategies were used, similar to other research, recruiting carers for participating in research was di cult. In addition, since this was a convenience sample, the generalizability is limited. Future research on MT4C should be conducted with larger sample sizes, and include a more random sampling approach." 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 brie y explain why the item is not applicable/relevant for your study not applicable, as MT4C was developed to be used by carers on an as needed basis and is self-administered. The site provides instructions on how each section can be used and does not require additional training. 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 brie y explain why the item is not applicable/relevant for your study "ClinicalTrials.gov Identi er: NCT02428387" 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 brie y explain why the item is not applicable/relevant for your study the protocol paper is cited throughout the manuscript and can be found in the reference list.
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 brie y explain why the item is not applicable/relevant for your study In addition to the usual declaration of interests ( nancial 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 brie y explain why the item is not applicable/relevant for your study there are no con icts of interest As a result of using this checklist, did you make changes in your manuscript? * STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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