Association Between User Engagement of a Mobile Health App for Gout and Improvements in Self-Care Behaviors: Randomized Controlled Trial

Background Mobile health (mHealth) apps represent a promising approach for improving health outcomes in patients with chronic illness, but surprisingly few mHealth interventions have investigated the association between user engagement and health outcomes. We aimed to examine the efficacy of a recommended, commercially available gout self-management app for improving self-care behaviors and to assess self-reported user engagement of the app in a sample of adults with gout. Objective Our objective was to examine differences in self-reported user engagement between a recommended gout app (treatment group) and a dietary app (active control group) over 2 weeks as well as to examine any differences in self-care behaviors and illness perceptions. Methods Seventy-two adults with gout were recruited from the community and three primary and secondary clinics. Participants were randomized to use either Gout Central (n=36), a self-management app, or the Dietary Approaches to Stop Hypertension Diet Plan (n=36), an app based on a diet developed for hypertension, for 2 weeks. The user version of the Mobile Application Rating Scale (uMARS, scale: 1 to 5) was used after the 2 weeks to assess self-reported user engagement, which included an open-ended question. Participants also completed a self-report questionnaire on self-care behaviors (scale: 1-5 for medication adherence and diet and 0-7 for exercise) and illness perceptions (scale: 0-10) at baseline and after the 2-week trial. Independent samples t tests and analysis of covariance were used to examine differences between groups at baseline and postintervention. Results Participants rated the gout app as more engaging (mean difference –0.58, 95% CI –0.96 to –0.21) and more informative (mean difference –0.34, 95% CI –0.67 to –0.01) than the dietary app at the 2-week follow-up. The gout app group also reported a higher awareness of the importance of gout (mean difference –0.64, 95% CI –1.27 to –0.003) and higher knowledge/understanding of gout (mean difference –0.70, 95% CI –1.30 to –0.09) than the diet app group at follow-up. There were no significant differences in self-care behaviors between the two groups postintervention. The gout app group also demonstrated stronger negative beliefs regarding the impact of gout (mean difference –2.43, 95% CI –3.68 to –1.18), stronger beliefs regarding the severity of symptoms (mean difference –1.97, 95% CI –3.12 to –0.82), and a stronger emotional response to gout (mean difference –2.38, 95% CI –3.85 to –0.90) at follow-up. Participant feedback highlighted the importance of tracking health-related information, customizing to the target group/individual, providing more interactive features, and simplifying information. Conclusions Participants found the commercially available gout app more engaging. However, these findings did not translate into differences in self-care behaviors. The gout app group also demonstrated stronger negative illness perceptions at the follow-up. Overall, these findings suggest that the development of gout apps would benefit from a user-centered approach with a focus on daily, long-term self-care behaviors as well as modifying illness beliefs. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12617001052325; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373217.

Recommended "Dose" * What do the instructions for users say on how often the app should be used?
Approx. Percentage of Users (starters) still using the app as recommended after 3 months * Is this a full powered effectiveness trial or a pilot/feasibility trial? * 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 fourdigit number at the end of the DOI, to be found at the bottom of each published article in JMIR) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGl… 7/49 1a) TITLE: Identi cation as a randomized trial in the title 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.
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 "Is user engagement of a mobile health app for gout associated with improvements in self-care behaviours? A randomized controlled trial"

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 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 Yes, we did not have any 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 brie y explain why the item is not applicable/relevant for your study Yes, see above for title and word 'gout' 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 "Participants were randomized to either Gout Central (n=36), a self-management app, or the Dash Diet Plan (n=36), an app based on a diet developed for hypertension and also recommended for gout." 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 Not applicable to our study as there was no extra support provided 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 "Seventy-two adults with gout were recruited from the community and from three primary and secondary clinics and randomized to trial one of the apps over two weeks. Participants were randomized to either Gout Central (n=36), a selfmanagement app, or the Dash Diet Plan (n=36), an app based on a diet developed for hypertension and also recommended for gout. The user-version of the Mobile Application Rating Scale (uMARS, 1 to 5 scale) was completed after two weeks to assess self-reported user-engagement, which included an open-ended question.
Participants also completed a self-report questionnaire on self-care behaviours (1-5 scale for medication adherence and diet and 0-7 for exercise) and illness perceptions (0-10 scale) at baseline and after the two-week trial. " 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)

INTRODUCTION
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 "Participants rated the gout app as more engaging ( 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 brie y explain why the item is not applicable/relevant for your study We discuss the gap in the literature in the introduction: "There are surprisingly few evidence-based apps which have been developed for patients with gout (7), despite affecting approximately 4% of US adults and rates increasing worldwide (8,9)." and "User engagement encompasses both how often and for how long people use apps, as well as the user's experience of the technology as a whole (21).
Engagement is therefore believed to be closely tied to effectiveness of the intervention (22). It is estimated that approximately 23% of app users delete an app after its rst use (23), however user engagement is often not reported as part of mHealth interventions (24), and surprisingly few mHealth interventions examine the association between user engagement and health outcomes ( 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 "Mobile health (mHealth) interventions represent a promising approach to reducing barriers to care and potentially improving adherence to effective treatments for gout. In 2016 Nguyen and colleagues (19) reviewed commercially available apps for managing gout available on iOS, and found that only one app met the recommendations set in patient-focused gout management guidelines.
In 2017 we expanded this search to also include Android smartphones and found a similar result (20)." 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 "Due to the these gaps in the literature, the goal of our study was to examine gout patients' experiences of using a commercially available gout self-management app compared to a dietary app, with a focus on assessing differences in user engagement, self-care behaviours and illness beliefs. Using a randomized controlled trial design, we compared the gout self-management app identi ed in the previous reviews of gout apps (7, 20) and a dietary app based on the DASH (Dietary Approaches to Stop Hypertension) diet, as the DASH diet is associated with a lower risk of gout (26). We predicted that the participants allocated to the gout self-management app would demonstrate higher user engagement, selfcare behaviours and more adaptive illness beliefs at the 2-week follow-up compared to the active control group." 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 brie y explain why the item is not applicable/relevant for your study "Participants were randomized to either Gout Central (treatment group), a commercially available self-management app for gout, or to the DASH Diet Plan (active control group), a commercially available app based on a diet for hypertension. Seventy-two adults with gout were recruited in Auckland and randomly allocated to trial one of the apps between August 2017 and May 2018." and "App group allocations were generated by a biostatistician at the School of Medicine independent of the intervention delivery. Randomization occurred via sealed envelopes labelled with sequential study numbers." 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 we did not make any methodological changes 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 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 "Furthermore, after data collection was completed for this study, the gout app Gout Central was updated, therefore these results may not re ect the most up-todate version of the app." 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 "Inclusion/exclusion criteria included a diagnosis of gout as de ned by the 2015 ACR-EULAR Gout Classi cation Criteria (27), (2) > 18 years old (3), ability to complete forms in English and provide informed consent, and (4) own or have access to an android or IOS smartphone device capable of downloading apps." 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 We did not assess computer/internet literacy, however our inclusion criteria included that participants own or have access to a smartphone device capable of 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 "Participants were recruited through posters in the community and from three primary and secondary clinics in Auckland, New Zealand." and "The baseline assessment occurred face-to-face (using hard-copy questionnaires) and the follow-up assessments/questionnaires were either completed as hard-copy questionnaires and posted to the research team or completed online." 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 "Participants who were allocated to use this app were advised to use all the functions they found helpful and were encouraged to use the app on a daily basis. They were also sent two text message reminders (two times during the 2- week trial period) to remind them to use the app on a daily basis. After the completion of the follow-up questionnaires they were sent a $50 voucher to thank them for their time." 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 "Participants were recruited through posters in the community and from three primary and secondary clinics in Auckland, New Zealand." 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 "All the self-report questionnaires were administered online or as hard copy questionnaires." 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 subitem not at all important 1 2 3 4 5 essential 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 All of the materials used for recruitment displayed the University of Auckland logo as required by the ethics committee.

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).
subitem not at all important 1 2 3 4 5 essential 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 as we evaluated two commercially available apps. However, we do of course mention the names of the apps and describe them, for example below is the description for the gout app: "The participants who were randomized to the treatment group were allocated to use the 'Gout Central' app for two weeks. This app includes information about gout, its causes, identi es common triggers which may cause ares, lifestyle tips for preventing gout ares and treatment options. In addition, this app also includes a series of health trackers such as the serum urate tracker and gout are tracker in which the user can enter their details and track changes across time.
Furthermore, this app allows users to enter their doctor appointments, log questions for their healthcare providers, log their medications and supplements used to manage gout and other conditions, and also links them to online resources."

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 Not applicable except for that we found out that one of the apps was updated after our trial ended, which we report in the Discussion: "Furthermore, after data collection was completed for this study, the gout app Gout Central was updated, therefore these results may not re ect the most up-to-date version of the app."

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 N/A 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 N/A

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

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 "After randomization, a research assistant helped participants download the app on their phones. The free versions of both apps were used in this study." 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 "The participants who were randomized to the treatment group were allocated to use the 'Gout Central' app for two weeks. This app includes information about gout, its causes, identi es common triggers which may cause ares, lifestyle tips for preventing gout ares and treatment options. In addition, this app also includes a series of health trackers such as the serum urate tracker and gout are tracker in which the user can enter their details and track changes across time.

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Furthermore, this app allows users to enter their doctor appointments, log questions for their healthcare providers, log their medications and supplements used to manage gout and other conditions, and also links them to online resources.
Participants who were allocated to use this app were advised to use all the functions they found helpful and were encouraged to use the app on a daily basis. They were also sent two text message reminders (two times during the 2- week trial period) to remind them to use the app on a daily basis. After the completion of the follow-up questionnaires they were sent a $50 voucher to thank them for their time." and "The active control group trialled the DASH diet plan app. This app provides information about the DASH (Dietary Approaches to Stop Hypertension) diet eating plan which has been shown to be effective in managing various health conditions such as gout (26). The app educates users about the DASH diet, provides information to allow users to create a diet action plan and informs users what foods are bene cial and which should be avoided. This app also provides various recipes and meal ideas for breakfast, lunch, dinner, dessert and snacks.
Participants who were allocated to use this app were also advised to use all the functions they found helpful and were encouraged to use the app on a daily basis. They also received the same text message reminders as the intervention group (two times during the two week period). After the completion of the followup questionnaires they were sent a $50 voucher to thank them for their time." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Participants who were allocated to use this app were also advised to use all the functions they found helpful and were encouraged to use the app on a daily basis. They also received the same text message reminders as the intervention group (two times during the two week period). "

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 21generalizability).
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 N/A ) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed 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).
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 "They were also sent two text message reminders (two times during the 2-week trial period) to remind them to use the app on a daily basis."

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. 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 There were no co-interventions used 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 "Demographic data, including sex, age and ethnicity was collected at baseline via self-report questionnaires. Current alcohol use ('do you drink alcohol', yes/no), smoking status ('do you smoke', yes/no) and physical activity ('Do you get at least 30 minutes of physical activity per day, e.g. brisk walking', yes/no) was also assessed at baseline. Disease duration, frequency of gout ares, comorbidities, serum urate, serum creatinine and current gout treatments were collected via self-report or from participants' medical records. Previous and current app use (including use of health apps) was also assessed in the baseline questionnaire.
All the self-report questionnaires were administered online or as hard copy questionnaires.

User engagement
Our primary outcome measure was user engagement, measured using a modi ed version of the Mobile Application Rating Scale (uMARS) (28, 29) and administered after the two-week trial. The original MARS was designed to allow app developers and health professionals to rate the quality of health apps while the adapted uMARS scale was developed to allow users to rate health apps. The uMARS can be used to derive three separate scores: the objective app quality score, the subjective app quality score, and the perceived impact score. The objective app quality score is derived using four subscales: engagement, functionality, aesthetics and information quality. All items are rated on a 1 to 5 Likert scale, where 1 indicates the app is inadequate in that domain and 5 indicates the app is excellent in that domain. A total score is calculated by averaging across the four domains. In the current study only two of the subscales were used (engagement and information) to reduce participant burden. Therefore, only individual domain scores are presented for the two subscales without a total objective app quality score.
The subjective app quality score is derived from four items that examine overall user experience: "Would you recommend this app to people who might bene t from it", "How many times do you think you would use this app in the next 12 months if it was relevant to you?", "Would you pay for the app?", and "What is your overall (star) rating of the app?" The four items are also rated on 1 to 5 Likert scale, where 1 is 'inadequate' and 5 is 'excellent' and are averaged for a total score. Lastly, the perceived impact score consists of six items which measure the impact of using the app on knowledge ("this app has increased my knowledge/understanding of the health behaviour"), attitude ("the app has changed my attitudes towards improving this health behaviour") and behaviour ("use of this app will increase/decrease the health behaviour" question "Do you have any further comments about the app?" The uMARS demonstrates good internal reliability for both the instrument overall and for the individual subscales within the instrument (29). The Cronbach's alpha coe cient for the engagement subscale score was 0.80, for the information subscale score was 0.60 and for the app subjective quality score was 0.84. In addition to the uMARS, two additional questions were included to assess how often and for how long participants used the apps. These were: "in the last 14 days, on how many days did you use the app" and "on the days that you used the app, approximately how many minutes did you spend using the app?"

Self-care behaviours
Adherence to gout self-management guidelines and self-care behaviours were assessed with a self-report questionnaire which covers behaviours related to gout management over the past 7 days. These items were adapted from the diabetes-speci c Multidimensional Diabetes Questionnaire (30) and have been used previously to assess self-care behaviours in gout (31). The items were individually scored and included behaviours such as medication (e.g. "over the last 7 days how many of your prescribed number of gout pills [e.g. allopurinol, probenecid, febuxostat or benzbromarone] did you take?") rated on a 5 point Likert scale from 1= 'none of them' to 5 = 'all of them'; exercise (e.g. "on how many of the last 7 days did you participate in at least 20 minutes of exercise?"), rated on a 8-point Likert scale from 0-7 days; and diet-related activities (e.g. "how often did you follow your recommended diet over the last 7 days?") rated on a 5 point Likert scale from 1 = 'Never' to 5 = 'Always'.

Illness perceptions Illness perceptions were measured using a gout-speci c Brief Illness Perceptions
Questionnaire (B-IPQ)(32). The 8-item B-IPQ examines the ve key illness perception dimensions as well as items measuring the patient's concern, understanding, and emotional response to illness. The eight items are measured on a 0-10 Likert scale, with higher scores indicative of stronger endorsement: consequences (how much gout affects the patient's life), timeline (how long the patient thinks gout will continue), personal control (how much control the patient has over his or her gout), treatment control (how much the patient's medication can control gout), identity (severity of gout symptoms), concern (how concerned the patient is about his or her gout), understanding (how well the patient feels he/she understand their gout), and emotional response (how much gout affects the patient emotionally.) The B-IPQ has satisfactory reliability and validity across a range of chronic illnesses (32 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 "In addition to the uMARS, two additional questions were included to assess how often and for how long participants used the apps. These were: "in the last 14 days, on how many days did you use the app" and "on the days that you used the app, approximately how many minutes did you spend using the app?"" 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? 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

No changes
subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 We did not take attrition into account, as our sample was much larger than what is recommended in the usability testing literature and because we did not have any previous studies from which to estimate the effect size: "Due to the lack of intervention studies which have examined differences in self-reported user engagement of health apps from which to estimate an effect size, we determined the sample size required to detect a medium effect size (0.6) between the two groups in user engagement (based on the uMARS). For the power calculation, we used an independent samples t-test with 80% power and a 5% signi cance level, which indicated 72 participants were required (36 in each group). To our knowledge, the only other study comparing user engagement scores (using the uMARS) across health apps used 5-6 participants per app group based on recommendations from the usability testing literature (33). The current power calculation was conducted based on recommendations for studies in which a standardised effect size is not known (34). " 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 N/A 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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 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 "App group allocations were generated by a biostatistician at the School of Medicine independent of the intervention delivery. Randomization occurred via sealed envelopes labelled with sequential study numbers." 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 N/A 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 "Randomization occurred via sealed envelopes labelled with sequential study numbers." 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 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 "App group allocations were generated by a biostatistician at the School of Medicine independent of the intervention delivery. Randomization occurred via sealed envelopes labelled with sequential study numbers. A research assistant recruited participants and assigned participants to interventions." 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 Participants and research staff were not blinded.
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 "Participants did not know which app was the intervention of interest/intervention group and which app was the control group." 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 N/A 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 "Independent samples t-tests and analysis of covariance (ANCOVA) for variables which were unbalanced at baseline were used to examine differences between groups post-intervention in user engagement, self-care behaviours and illness perceptions. The results remained unchanged when controlling for baseline covariates, therefore un-adjusted means are reported. Means, standard errors, and 95% con dence intervals are presented with the analyses." subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item) 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 brie y explain why the item is not applicable/relevant for your study "Out of the 72 participants, 9 were lost to follow-up and did not complete any of the follow-up questionnaires (Figure 1). The analysis therefore constituted a per protocol analysis." 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 As above "The analysis therefore constituted a per protocol analysis. Independent samples t-tests and analysis of covariance (ANCOVA) for variables which were unbalanced at baseline were used to examine differences between 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 "Ethics approval was granted by the Health and Disability Ethics Committee 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 As above

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 N/A 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 This is reported in the statistical analyses and in the consort diagram ( Figure 1).
"Out of the 72 participants, 9 were lost to follow-up and did not complete any of the follow-up questionnaires (Figure 1). The analysis therefore constituted a per protocol analysis." 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 See Figure 1 https 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 This was not possible, as we were evaluating commercially available apps.
However we did assess self-reported use of the app over the 2-week time period.
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 "Seventy-two adults with gout were recruited in Auckland and randomly allocated to trial one of the apps between August 2017 and May 2018." 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 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 N/A 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 Table 1 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 brie y explain why the item is not applicable/relevant for your study We did not assess socioeconomic status or ehealth literacy. We did assess age, ethnicity and gender (see Table 1).
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 prede ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "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 brie y explain why the item is not applicable/relevant for your study This was not possible to do as we were assessing use of the apps using selfreport after the 2 week trial.

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 Due to having no follow-up data for nine participants, the most appropriate analysis was a per protocol analysis: "Another limitation was our short follow-up and the per protocol analysis, which no longer constitutes a randomized sample." 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) 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 We have reported the effect sizes in the manuscript text and results for each group (with CIs) in the tables.
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 This was not possible to do, as we were evaluating a commercially available app rather than our own app. 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 We have reported means, differences in means and Cohen's d in the text or tables 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 We have reported adjusted analyses for variables which were not balanced at baseline.

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 We did a per protocol analysis, whereby all of the participants used the app at least once.
subitem not at all important 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 We analysed the open-ended question from the uMARS, where we collated negative as well as positive feedback (see Table 4) 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 brie y explain why the item is not applicable/relevant for your study As above DISCUSSION 22) Interpretation consistent with results, balancing bene ts and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential 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).
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 "This is the rst study to trial a commercially available gout app to examine the impact on health outcomes. This is also the rst study to examine the utility of a commercially available gout app from the patient's perspective, by examining user engagement. Our primary hypothesis was largely con rmed by the ndings, Does your paper address subitem 22-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 "Due to the short follow-up in the current study, we cannot con rm either of these possibilities or whether the change in illness perceptions will be sustained and/or in uence self-care behaviours in the long-term.
Targeting illness perceptions presents another promising area for future research in mHealth interventions. Only a handful of mHealth interventions have attempted to modify illness perceptions (39-41), with promising effects on outcomes including medication adherence as well as objective health outcomes.
Considering that many commercially available health apps lack theory or evidence-based behavioural strategies (42-44), this could be an important area for future research. "

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 nonuse 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 subitem not at all important 1 2 3 4 5 essential 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 "There are also several limitations that should be noted. As we did not develop the apps, we were also unable to objectively examine user engagement and had to rely on self-report. Furthermore, after data collection was completed for this study, the gout app Gout Central was updated, therefore these results may not re ect the most up-to-date version of the app. Another limitation was our short follow-up and the per protocol analysis, which no longer constitutes a randomized sample. Lastly, these ndings may not be generalizable to other populations."

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 As above 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 N/A 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 "The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) (registration number ACTRN12617001052325)." 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 N/A 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Con icts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist 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 "AS was supported by the University of Auckland's Faculty Research Development Fund grant." X27-i) State the relation of the study team towards the system being evaluated 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 "The authors have no con ict of interest." 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?
Clari ed the abstract How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * 2 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 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.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary le.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you!