Telehealth Rehabilitation for Cognitive Impairment: Randomized Controlled Feasibility Trial

Background Nonpharmacological interventions are needed to support the function of older adults struggling with subjective cognitive impairment (SCI), mild cognitive impairment (MCI), and dementia due to Alzheimer disease (AD). Telerehabilitation aims to provide rehabilitation at a distance, but cognitive rehabilitation by videoconferencing has not been explored. Objective The objective of this study was to compare goal-oriented cognitive rehabilitation delivered in-person with videoconferencing to determine whether telehealth cognitive rehabilitation appears feasible. Methods Random assignment to in-person or telehealth videoconferencing cognitive rehabilitation with a combined between-subjects, multiple baseline single-case experimental design, cognitive rehabilitation was delivered by a therapist to 6 participants with SCI (n=4), MCI (n=1), or dementia due to AD (n=1). Results Two of the 6 participants randomly assigned to the telehealth condition withdrew before beginning the intervention. For those who participated in the intervention, 6 out of 6 goals measured with the Canadian Occupational Performance Measure improved for those in the in-person group, and 7 out of 9 goals improved for those in the telehealth group. Conclusions Delivery of cognitive rehabilitation by telehealth appeared feasible but required modifications such as greater reliance on caregivers and clients for manipulating materials.


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) 1 2 3 4 5 subitem not at all important essential

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 briepy explain why the item is not applicable/relevant for your study 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 briepy explain why the item is not applicable/relevant for your study 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) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons.

3b-i) Bug Uxes, Downtimes, Content Changes
Bug Uxes, 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 Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inpuenced 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 briepy explain why the item is not applicable/relevant for your study 4a) Eligibility criteria for participants 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 briepy explain why the item is not applicable/relevant for your study

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.

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 briepy explain why the item is not applicable/relevant for your study 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. ooine), 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 quasianonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conUrmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study

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.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study 4b) Settings and locations where the data were collected

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 briepy explain why the item is not applicable/relevant for your study 5) The interventions for each group with sutcient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, a.liations of the developers, sponsors, and owners
Mention names, credential, atliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conpict of interest" section or mentioned elsewhere in the manuscript).
subitem not at all important 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 briepy explain why the item is not applicable/relevant for your study

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.

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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).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iii?
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5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study

5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture 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 powcharts of the algorithms used.Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc 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 briepy explain why the item is not applicable/relevant for your study

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 briepy 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 speciUc 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).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 briepy explain why the item is not applicable/relevant for your study

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.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study

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).
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study

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).Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored (logins, logUle 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 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).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text 6b) Any changes to trial outcomes after the trial commenced, with reasons

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 briepy explain why the item is not applicable/relevant for your study 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed

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 briepy explain why the item is not applicable/relevant for your study 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 briepy explain why the item is not applicable/relevant for your study 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 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)

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 briepy explain why the item is not applicable/relevant for your study 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 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 briepy explain why the item is not applicable/relevant for your study

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]).
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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 briepy explain why the item is not applicable/relevant for your study X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)

X26-i) Comment on ethics committee approval
1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-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 briepy explain why the item is not applicable/relevant for your study

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained ooine 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 briepy explain why the item is not applicable/relevant for your study

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) 1 2 3 4 5 subitem not at all important essential

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 briepy explain why the item is not applicable/relevant for your study 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 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 briepy explain why the item is not applicable/relevant for your study 13b) For each group, losses and exclusions after randomisation, together with reasons

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 briepy explain why the item is not applicable/relevant for your study 14b) Why the trial ended or was stopped (early)

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.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

16-i) Report multiple "denominators" and provide deUnitions
Report multiple "denominators" and provide deUnitions: 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 speciUc pre-deUned time points of interest (in absolute and relative numbers per group).Always clearly deUne "use" of the intervention.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study

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).
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) 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 briepy explain why the item is not applicable/relevant for your study

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 deUnitions 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 deUned (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 briepy explain why the item is not applicable/relevant for your study 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended

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).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

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 briepy explain why the item is not applicable/relevant for your study 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 briepy explain why the item is not applicable/relevant for your study Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
1 2 3 4 5 subitem not at all important 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 briepy explain why the item is not applicable/relevant for your study 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. ooine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment).Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials).Note: In traditional ooine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered.To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e.participants can self-enrol).(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential (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) and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program?Intended for a particular patient population?Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions?(Note: Details about the intervention are provided in "Methods" under 5relevant 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 briepy explain why the item is not applicable/relevant for your study 2a-ii) ScientiUc background, rationale: What is known about the (type of) system ScientiUc background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this speciUc study, from which stakeholder viewpoint is the study performed, potential impact of Undings[2].Briepy justify the choice of the comparator.
all important essential 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 briepy explain why the item is not applicable/relevant for your study 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework [6] used to design them (instructional strategy [1], behaviour change techniques, persuasive features, etc., see e.g., [7, 8] for terminology).This includes an in-depth description of the content (including where it is coming from and who developed it) [1]," whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback" [6].This also includes a description of communication delivery channels and -if computer-mediated communication is a component -whether communication was synchronous or asynchronous [6].It also includes information on presentation strategies [1], including page design principles, average amount of text on pages, presence of hyperlinks to other resources, etc. [1]. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-viii?* 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 briepy explain why the item is not applicable/relevant for your study 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. 1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study 6a) Completely deUned pre-speciUed primary and secondary outcome measures, including how and when they were assessedDoes 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 briepy explain why the item is not applicable/relevant for your study 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9Copy and paste relevant sections from manuscript text 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored

DISCUSSION 22 )
Interpretation consistent with results, balancing beneUts 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 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use)

4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly
report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.subitemnot at all

important essential 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 briepy explain why the item is not applicable/relevant for your study

4b-ii) Report how institutional a.liations are displayed Report
how institutional atliations are displayed to potential participants [on ehealth media], as atliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Nota required item -describe only if this may bias results)

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 briepy explain why the item is not applicable/relevant for your study 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group * 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 briepy explain why the item is not applicable/relevant for your study 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 briepy explain why the item is not applicable/relevant for your study 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 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 briepy explain why the item is not applicable/relevant for your study 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions NPT: Whether or not administering co-interventions were blinded to group assignment 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 CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ^ow diagram)
Copy and paste relevant sections from the manuscript or cite the Ugure 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 briepy explain why the item is not applicable/relevant for your study 14a) Dates deUning the periods of recruitment and followupCopy 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 briepy explain why the item is not applicable/relevant for your study *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 briepy explain why the item is not applicable/relevant for your study13b-i) Attrition diagramStrongly 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 Ugures or tables demonstrating usage/dose/engagement.

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signiUcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources"

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 briepy explain why the item is not applicable/relevant for your study 15) A table showing baseline demographic and clinical characteristics for each group NPT: When applicable, a description of care providers (case volume, qualiUcation, expertise, etc.) and centers (volume) in each groupCopy 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 briepy explain why the item is not applicable/relevant for your study

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 briepy explain why the item is not applicable/relevant for your study 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory 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 briepy explain why the item is not applicable/relevant for your study 19) All important harms or unintended effects in each group (for speciUc guidance see CONSORT for harms)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 briepy explain why the item is not applicable/relevant for your study