Lessons Learned From an Effectiveness Evaluation of Inlife, a Web-Based Social Support Intervention for Caregivers of People With Dementia: Randomized Controlled Trial

Background Informal care for people with dementia not only affects the well-being of the primary caregiver but also changes their roles and interactions with the social environment. New online interventions might facilitate access to social support. Recently, an online social support platform, Inlife, was developed in the Netherlands and aims to enhance social support and positive interactions in informal support networks. Objective This study aimed to evaluate the effectiveness of Inlife for caregivers of people with dementia. Methods A randomized controlled trial with 96 caregivers of people with dementia was performed. Participants were randomly assigned to the Inlife intervention or the waiting list control group. After 16 weeks of Inlife use, the waiting list control group could start using Inlife. Effects were evaluated at baseline (T0), 8 weeks (T1), and 16 weeks (T2). The 16-week follow-up assessment (T2) served as the primary endpoint to evaluate the results for the primary and secondary outcome variables evaluated with online self-report questionnaires. The primary outcomes included feelings of caregiver competence and perceived social support. The secondary outcomes included received support, feelings of loneliness, psychological complaints (eg, anxiety, stress), and quality of life. Results No significant improvements were demonstrated for the intervention group (n=48) relative to the control group (n=48) for the primary outcomes (feeling of carer competence: b=–0.057, 95% CI –0.715 to 0.602, P=.87; perceived social support: b=–15.877, 95% CI –78.284 to 46.530, P=.62) or any secondary outcome. This contrasts with our qualitative findings showing the potential of Inlife to facilitate the care process in daily life. Adherence was not optimal for all Inlife users. Additional per-protocol and sensitivity analyses also revealed no beneficial results for high active Inlife users or specific subgroups. Inlife users were more active when part of a larger network. Conclusions Researchers should be modest regarding the effectiveness of online caregiver interventions in terms of quantitative measures of well-being and quality of life. Nevertheless, online tools have the potential to facilitate the caregiver process in daily life. Lessons learned include the importance of harnessing the power of human interaction in eHealth, making use of the user’s social capital, and the need to develop research methods that can identify benefits in daily life that are ecologically valid for caregivers. Trial Registration Netherlands Trial Register NTR6131; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6131 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-017-2097-y

https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…l=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full yes: all primary outcomes were signiPcantly better in intervention group vs control partly: SOME primary outcomes were signiPcantly better in intervention group vs control no statistically signiPcant difference between control and intervention potentially harmful: control was signiPcantly better than intervention in one or more outcomes inconclusive: more research is needed Other: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) ms#38656 1a) Does your paper address CONSORT item 1a? * 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 orine 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 briesy explain why the item is not applicable/relevant for your study The title was: Inlife, an "online" social support intervention for caregivers of people with dementia: effect evaluation and lessons learned in a randomised controlled trial. As it has already been submitted for review, it will be changed in the next version to: Inlife, a "webbased" social support intervention for caregivers of people with dementia: effect evaluation and lessons learned in a randomised controlled trial

1a-ii) Non-web-based components or impoHant co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support"). https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…l=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 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 briesy explain why the item is not applicable/relevant for your study The title was: Inlife, an online social support intervention for caregivers of people with "dementia": effect evaluation and lessons learned in a randomised controlled trial. As it has already been submitted for review, it will be changed in the next version to: Inlife, a webbased" social support intervention for caregivers of people with dementia: effect evaluation and lessons learned in a randomised controlled trial https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…l=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 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 briesy explain why the item is not applicable/relevant for your study Yes: "Recently, an online social support platform, Inlife, was developed in the Netherlands aiming to enhance social support and positive interactions in informal support networks." As it has already been submitted for review, it will be changed in the next version to include MRC framework 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) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 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 briesy explain why the item is not applicable/relevant for your study As it has already been submitted for review, it will be changed in the next version to a description of the intervention as "fully automated" 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. orine), 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 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 briesy explain why the item is not applicable/relevant for your study As it has already been submitted for review, it will be changed in the next version to include that "the assessments were unblinded, web-based self-assessments using questionnaires, with participants who were recruited orine via syers and Alzheimer Cafe presentations. 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 briesy explain why the item is not applicable/relevant for your study As it has already been submitted for review, it will be changed in the next version to include that the adherence data and use over time 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 briesy explain why the item is not applicable/relevant for your study "Results: No signiPcant improvements were demonstrated for the intervention group relative to the control group on primary and secondary outcome measures. This contrasts with our qualitative Pndings showing the potential of Inlife to facilitate the care process in daily life. Adherence was not optimal for all Inlife users. Additional per protocol and sensitivity analysis also revealed no benePcial results for high active Inlife users or speciPc subgroups. Inlife users were more active when were part of a larger network. " As it has already been submitted for review, it will be changed in the next version to include potential reasons discussed in the manuscript discussion.

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Therefore, the online social support intervention 'Inlife' was developed for caregivers of PwD and made available in the Netherlands [22]. 'Inlife' intends to help caregivers of PwD overcome barriers to seeking help, while also removing barriers to the wider environment offering help. Using the 'Inlife platform', the primary caregiver is encouraged to invite family, friends, and signiPcant others into their personalised support circles." "Inlife is currently being called 'Myinlife', after being adopted by a societal partner, the Dutch Alzheimer's association (Alzheimer Nederland)." As it has already been submitted for review, it will be changed in the next version to include that it was intended as a standalone intervention, but has now been adopted in the broader Dutch Alzheimer's Association dementia platform. 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 briesy explain why the item is not applicable/relevant for your study "Consequently, informal caring not only affects the wellbeing of the primary caregiver but also changes their roles and interactions with the social environment [2,3]. Although some involved caregivers report the benePts of caring, such as the strengthening and enrichment of mutual relationships, family cohesion or personal growth [4], others face negative consequences of caring to their physical and mental health or experience increased burden due to the growing dependence of the PwD on their environment [2,5]. During the disease process, caregivers of PwD are at risk of becoming socially isolated since they might become homebound due to decreased mobility, memory problems, behavioural problems, denial of the disease, or experienced stigma [6][7][8].
To prevent social isolation and loneliness in caregivers and PwD, support is needed after a diagnosis has been made. Existing psychosocial interventions focus on psychoeducation, skill building, and psychotherapeutic counselling based on techniques derived from cognitive behavioural therapy (CBT) [9][10][11]. It has been demonstrated that individually tailored, multi-component interventions offered to both the caregiver and the PwD have positive effects on burden, anxiety and depression [9][10][11]. " 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 briesy explain why the item is not applicable/relevant for your study "The aim was to evaluate the effectiveness of Inlife in a randomised controlled trial (RCT) over a 16-week period [23]. Primary outcomes were feelings of competence and perceived social support. Secondary outcomes were received support, feelings of loneliness, psychological complaints, and quality of life. We hypothesised that compared with care as usual, use of the Inlife intervention would lead to change in both the primary and secondary outcome measures." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) ImpoQant changes to methods aRer trial commencement (such as eligibility criteria), with reasons 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 briesy explain why the item is not applicable/relevant for your study "After the baseline assessment, participants were randomly assigned to either the intervention or a waiting list control group. The intervention group participated in the Inlife intervention. The waiting-list control group received 'care-as-usual' and was able to start with Inlife after 16 weeks. Randomisation was performed using a computerised sequence generator for block randomisation with variable sizes of four, six and eight [for details see [23]]. The follow-up assessments were completed online using a secure, custom-designed query system." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 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 briesy explain why the item is not applicable/relevant for your study There were none, though inclusion was less than the power calculation.
"Sample size calculation was based on previous intervention studies of caregivers of PwD with the Short Sense of Competence Questionnaire (SSCQ) as an outcome measure [16,36], using differences between intervention and controls at follow-up with an assumed mean effect size of Cohen's d=0.5 (medium effect). With an alpha of 0.05 and power of 80%, we aimed to include n=102 primary caregivers (51 participants per group). Allowing for a 20% loss to follow up, we aimed to enrol a total of 122 caregivers into the study." "A total of 475 caregivers were approached to participate in the study. After the screening, 351 caregivers were eligible for participation. In total, 96 caregivers signed informed consent and were randomly assigned to either the Inlife intervention group (n=48) or the waiting-list control group (n=48 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 briesy explain why the item is not applicable/relevant for your study

Your answer
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 briesy explain why the item is not applicable/relevant for your study "The inclusion criteria were 1) being a primary, informal caregiver of a person diagnosed with dementia of all subtypes, 2) having Internet access, and 3) having basic (tablet) computer knowledge as assessed by the researcher. Participants were excluded if they were unavailable during the study period for longer than four weeks or had serious health problems incompatible with participation as assessed by the study staff."
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 briesy explain why the item is not applicable/relevant for your study "The inclusion criteria were 1) being a primary, informal caregiver of a person diagnosed with dementia of all subtypes, 2) having Internet access, and 3) having basic (tablet) computer knowledge as assessed by the researcher. Participants were excluded if they were unavailable during the study period for longer than four weeks or had serious health problems incompatible with participation as assessed by the study staff." 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. orine), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conPrmation, 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 briesy explain why the item is not applicable/relevant for your study As it has already been submitted for review, it will be changed in the next version to include that "the assessments were unblinded, web-based self-assessments using questionnaires, with participants who were recruited orine via syers and Alzheimer Cafe presentations." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 4b) SeUings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study

Your answer
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 briesy explain why the item is not applicable/relevant for your study As it has already been submitted for review, it will be changed in the next version to include that the questionnaires were completed online. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b-i) RepoH 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.
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 briesy explain why the item is not applicable/relevant for your study " Assessments were collected online at three time-points, pre-intervention (T0), 8-weeks (T1), and 16-weeks (T2). The 16-week follow-up assessment served as a primary endpoint to compare group effects [23]. "

4b-ii) RepoH how institutional aFliations 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 briesy explain why the item is not applicable/relevant for your study Your answer https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 5) The interventions for each group with suWcient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, aFliations 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 "Consict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Inlife is currently being called 'Myinlife', after being adopted by a societal partner, the Dutch Alzheimer's association (Alzheimer Nederland)."

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. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Therefore, the online social support intervention 'Inlife' was developed for caregivers of PwD and made available in the Netherlands [22]. 'Inlife' intends to help caregivers of PwD overcome barriers to seeking help, while also removing barriers to the wider environment offering help. Using the 'Inlife platform', the primary caregiver is encouraged to invite family, friends, and signiPcant others into their personalised support circles. The functionalities on the intervention include ProPle (personal information), Circles (layers of caregivers with different privileges), Helping (general overview to place and receive responses to help requests), Timeline, Calendar, Personal Messages, Care Book, and Compass (information about dementia-related topics). Details concerning these functionalities are described elsewhere [23]"

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

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing fowchaHs of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing sowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiPc reporting. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 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 briesy explain why the item is not applicable/relevant for your study Your answer

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 briesy 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 speciPc 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 briesy explain why the item is not applicable/relevant for your study "The intervention group had access to Inlife, an online social support platform for informal caregivers and PwD aimed at strengthening positive interactions and social support. All users had a secure username and password combination to access the website and complementary app for smartphones and tablets. Participants could use Inlife in a sexible manner and at their own pace. The platform remained accessible to them after the 16-week study period. Participants in the control group remained on the waiting list for 16 weeks and received care as usual. After the 16-week follow-up assessment (T2), they had the opportunity to register on the Inlife platform. 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 briesy explain why the item is not applicable/relevant for your study "Therefore, the online social support intervention 'Inlife' was developed for caregivers of PwD and made available in the Netherlands [22]. 'Inlife' intends to help caregivers of PwD overcome barriers to seeking help, while also removing barriers to the wider environment offering help. Using the 'Inlife platform', the primary caregiver is encouraged to invite family, friends, and signiPcant others into their personalised support circles. The functionalities on the intervention include ProPle (personal information), Circles (layers of caregivers with different privileges), Helping (general overview to place and receive responses to help requests), Timeline, Calendar, Personal Messages, Care Book, and Compass (information about dementia-related topics). Details concerning these functionalities are described elsewhere [23]. Inlife is currently being called 'Myinlife', after being adopted by a societal partner, the Dutch Alzheimer's association (Alzheimer Nederland)." As the manuscript has already been submitted for review, the next version will include a description of Inlife's asynchronous communication and information on presentation strategies, including page design principles, average amount of text on pages, presence of hyperlinks to other resources, etc. We will elaborate on the design principles, that are described in the feasibility 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.
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 briesy explain why the item is not applicable/relevant for your study Your answer

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). https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 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 briesy explain why the item is not applicable/relevant for your study Your answer

5-xi) RepoH 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 briesy explain why the item is not applicable/relevant for your study "Two weeks after registration on the Inlife platform, all participants were contacted by phone to resect on user experiences." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 6a) Completely de6ned pre-speci6ed primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/suppoH) 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 briesy explain why the item is not applicable/relevant for your study There were no co-interventions involved. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 briesy explain why the item is not applicable/relevant for your study "Primary outcomes: First, caregiver sense of competence assessed by the Short Sense of Competence Questionnaire (SSCQ), which consisted of seven items that refer to caregivers' feelings of being capable of caring for the PwD. The total score ranged from 0 to 7. The SSCQ has been evaluated as a valid and reliable instrument in caregiver research [24]. Next, perceived support was measured using the 12-item Multidimensional Scale of Perceived Support (MSPSS). The total score ranges from 12 to 84. Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
Your answer 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was deaned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was dePned/measured/monitored (logins, logPle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii? subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes aRer 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 paHicipants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text

Your answer
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 briesy explain why the item is not applicable/relevant for your study No trial outcomes were changes after the trial commenced. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 ajrition 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 briesy explain why the item is not applicable/relevant for your study

Your answer
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 briesy explain why the item is not applicable/relevant for your study There were no interim analyses.
"Statistical analyses were conducted in IBM SPSS Statistics (IBM Corp. Released 2016. IBM SPSS Statistics for Macintosh, Version 24.0. Armonk, NY: IBM Corp). Before analysis, data were examined for missing values, outliers and normality. Potential differences between the intervention and control group in baseline characteristics and outcome variables at baseline and the 16-week follow-up, which might require adjustment for such differences, were tested using either t-tests for continuous variables or Chi-square (X2) tests for categorical variables. Since there were missing values, we compared the baseline characteristics of study completers and the participants with missing values" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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) 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 briesy explain why the item is not applicable/relevant for your study "After the baseline assessment, participants were randomly assigned to either the intervention or a waiting list control group. The intervention group participated in the Inlife intervention. The waiting-list control group received 'care-as-usual' and was able to start with Inlife after 16 weeks. Randomisation was performed using a computerised sequence generator for block randomisation with variable sizes of four, six and eight [for details see [23]]. The follow-up assessments were completed online using a secure, custom-designed query system." 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 briesy explain why the item is not applicable/relevant for your study "After the baseline assessment, participants were randomly assigned to either the intervention or a waiting list control group. The intervention group participated in the Inlife intervention. The waiting-list control group received 'care-as-usual' and was able to start with Inlife after 16 weeks. Randomisation was performed using a computerised sequence generator for block randomisation with variable sizes of four, six and eight [for details see [23]]. The follow-up assessments were completed online using a secure, custom-designed query system." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 paQicipants, and who assigned paQicipants to interventions 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 briesy explain why the item is not applicable/relevant for your study "After the baseline assessment, participants were randomly assigned to either the intervention or a waiting list control group. The intervention group participated in the Inlife intervention. The waiting-list control group received 'care-as-usual' and was able to start with Inlife after 16 weeks. Randomisation was performed using a computerised sequence generator for block randomisation with variable sizes of four, six and eight [for details see [23]]. The follow-up assessments were completed online using a secure, custom-designed query system." 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 briesy explain why the item is not applicable/relevant for your study "After the baseline assessment, participants were randomly assigned to either the intervention or a waiting list control group. The intervention group participated in the Inlife intervention. The waiting-list control group received 'care-as-usual' and was able to start with Inlife after 16 weeks. Randomisation was performed using a computerised sequence generator for block randomisation with variable sizes of four, six and eight [for details see [23]]. The follow-up assessments were completed online using a secure, custom-designed query system." 11a) If done, who was blinded aRer assignment to interventions (for example, paQicipants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

Does your paper address subitem 11a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The next version will specify that this trial was unblinded.
11a-ii) Discuss e.g., whether paHicipants 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". https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 briesy explain why the item is not applicable/relevant for your study

Your answer
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 briesy explain why the item is not applicable/relevant for your study The next version will specify that this trial was unblinded.
"Participants in the control group remained on the waiting list for 16 weeks and received care as usual." 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 briesy explain why the item is not applicable/relevant for your study "Statistical analyses were conducted in IBM SPSS Statistics (IBM Corp. Released 2016. IBM SPSS Statistics for Macintosh, Version 24.0. Armonk, NY: IBM Corp). Before analysis, data were examined for missing values, outliers and normality. Potential differences between the intervention and control group in baseline characteristics and outcome variables at baseline https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full intervention and control group in baseline characteristics and outcome variables at baseline and the 16-week follow-up, which might require adjustment for such differences, were tested using either t-tests for continuous variables or Chi-square (X2) tests for categorical variables. Since there were missing values, we compared the baseline characteristics of study completers and the participants with missing values. A separate analysis revealed that missingness was related to the sex of the PwD. Since missing values were not completely at random, data were analysed according to 'intention-to-treat' (ITT) applying a multiple imputation strategy. We used the Markov chain Monte Carlo (MCMC) method in SPSS to produce ten datasets. These were subsequently analysed, and estimates were pooled using Rubin's rule [37]. Subsequently, we performed a 'per protocol' analysis (PPT) including only the caregivers in the analyses that used Inlife until 16 weeks in the intervention group. A subsequent sensitivity analysis was conducted by contrasting the high active vs. the low active Inlife users with the control group. The intervention group was split in high active and low active Inlife users based on the median of the total number of clicks on the platform [23].
To test the differences in the outcome variables in the intervention group and waiting-list control group, we performed linear regression analysis on the imputed datasets, with outcomes from the T2 assessment as dependent variables (i.e., the primary endpoint at 16 weeks, after this period the waiting-list control group was able to start with Inlife). The primary and secondary outcome variables at the T2 follow-up were included in the model as dependent variables, and group as the between-subjects variable. Statistically signiPcant baseline differences between the treatment arms were included as covariates (e.g., age of the PwD). Each outcome measure was assessed as a dependent variable in separate analyses. For a variable that was positively skewed, a cubic transformation was applied to better approximate a normal distribution. Subsequently, to test the changes in the primary outcome measures over time, data were analysed performing a linear mixed model (LMM) on the non-imputed dataset. This analysis estimates the Pxed effects of the regression slopes, indicating the changes during the intervals (T0-T1) and (T1-T2) in the intervention and waiting-list control groups. This procedure allows for modelling the rate of change in the primary outcome variables in the caregivers who did not receive the intervention compared to the caregivers who received the intervention (T0-T2). This analysis accounts for within-subject correlations between repeated measures using random (i.e., individual-speciPc) effects, thus accounting for the hierarchical structure in the data (i.e., time nested in individuals). Additionally, LMM handles missing values e{ciently under the missing at random (MAR), assumption if variables that are associated with missingness are included in the analyses using maximum likelihood estimates for the missing observations. Hence, it is suitable for intention-to-treat analysis [38]. Random effects for the intercept only were speciPed because likelihood ratio testing revealed that this model Pt the data better than adding a random slope or adjusting for correlated residuals. To model the effect of the intervention on the primary outcome variables over time, we entered a group-by-time interaction term as a dummy variable for each of the follow-ups to allow for nonlinear effects. The model was adjusted for baseline differences (e.g., age of the PwD) and associations with missingness (e.g., sex of the PwD). All tests were two-tailed with an alpha level of 0.05." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with ajrition / 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 briesy explain why the item is not applicable/relevant for your study "A separate analysis revealed that missingness was related to the sex of the PwD. Since missing values were not completely at random, data were analysed according to 'intentionto-treat' (ITT) applying a multiple imputation strategy. We used the Markov chain Monte Carlo (MCMC) method in SPSS to produce ten datasets. These were subsequently analysed, and estimates were pooled using Rubin's rule [37]. Subsequently, we performed a 'per protocol' analysis (PPT) including only the caregivers in the analyses that used Inlife until 16 weeks in the intervention group. A subsequent sensitivity analysis was conducted by contrasting the high active vs. the low active Inlife users with the control group. The intervention group was split in high active and low active Inlife users based on the median of the total number of clicks on the platform [23]." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Considering our heterogeneous group, we performed a post hoc sensitivity analysis splitting the data into low active and high active users (Appendix 2), caregiver relationship status (spouse vs. children/others at distance) and living situation of the PwD (home vs. institution). This analysis revealed no signiPcant differences between the caregiver groups at T2 (See Appendix 2)."

X26-i) Comment on ethics commijee approval
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 briesy explain why the item is not applicable/relevant for your study 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 briesy explain why the item is not applicable/relevant for your study Your answer

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Your answer https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full RESULTS 13a) For each group, the numbers of paQicipants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers peqorming 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 aRer randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study Yes, see sowchart in manuscript.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT fow 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 briesy explain why the item is not applicable/relevant for your study https://docs. 14b) Why the trial ended or was stopped (early) 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 briesy explain why the item is not applicable/relevant for your study "Between June 2016 and June 2017, informal primary caregivers of people with dementia of all subtypes and stages were recruited via online advertisement, newsletters, and social media channels of the Dutch Alzheimer Association, regional dementia community services and through memory clinics or other relevant care institutions." "Participants were screened by telephone to check eligibility. Subsequently, the participating caregivers provided online informed consent. Assessments were collected online at three time-points, pre-intervention (T0), 8-weeks (T1), and 16-weeks (T2). The 16-week follow-up assessment served as a primary endpoint to compare group effects [23]. Two weeks after registration on the Inlife platform, all participants were contacted by phone to resect on user experiences."

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signiPcant 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 briesy 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 briesy explain why the item is not applicable/relevant for your study It was not ended or stopped early.
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 briesy explain why the item is not applicable/relevant for your study Yes see Table 1  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 briesy explain why the item is not applicable/relevant for your study Some of these data points (age, gender, education) were collected -see Table 1 in manuscript

16-i) RepoH multiple "denominators" and provide deanitions
Report multiple "denominators" and provide dePnitions: 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 speciPc pre-dePned time points of interest (in absolute and relative numbers per group). Always clearly dePne "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 briesy explain why the item is not applicable/relevant for your study This will be added in the next version of the manuscript. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated egect size and its precision (such as 95% con6dence interval)

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

Your answer
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 briesy explain why the item is not applicable/relevant for your study Yes see Table 2  subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative egect sizes is recommended 18) Results of any other analyses peiormed, including subgroup analyses and adjusted analyses, distinguishing pre-speci6ed from exploratory 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 dePnitions 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 dePned (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 briesy explain why the item is not applicable/relevant for your study

Your answer
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 briesy explain why the item is not applicable/relevant for your study 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 briesy explain why the item is not applicable/relevant for your study "Considering our heterogeneous group, we performed a post hoc sensitivity analysis splitting the data into low active and high active users (Appendix 2), caregiver relationship status (spouse vs. children/others at distance) and living situation of the PwD (home vs. institution). This analysis revealed no signiPcant differences between the caregiver groups at T2 (See Appendix 2)."

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 briesy explain why the item is not applicable/relevant for your study Your answer https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study "Conversely, it is possible that the Inlife intervention could have unintentionally induced a heightened awareness of one's lack of available support in circles with a low level of responsiveness, which may otherwise not have been salient. This could be a contributing factor to the suboptimal compliance to Inlife. " In discussion -not a direct result

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 briesy explain why the item is not applicable/relevant for your study 22-i) Restate study questions and summarize the answers suggested by the data, staHing 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 briesy explain why the item is not applicable/relevant for your study "This RCT evaluated 'Inlife', an online social support intervention for caregivers of PwD. No signiPcant improvements for the primary or secondary outcome variables were demonstrated for the intervention group relative to the control group. Additional per protocol and sensitivity analyses revealed no benePcial results for the high active Inlife users or speciPc subgroups of caregivers (i.e., spouse vs. children/ community dwelling vs. institutionalised). However, the results indicated that users in general were more active when they had a larger number of people in their Inlife network. Furthermore, active users tended to have slightly longer care duration." NPT: External validity of the trial andings according to the intervention, comparators, patients, and care providers or centers involved in the trial Does your paper address subitem 22-ii?

22-ii) Highlight unanswered new questions, suggest future research
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 briesy explain why the item is not applicable/relevant for your study Your answer

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briesy explain why the item is not applicable/relevant for your study The paper does discuss limitations, but next version will add the described typical limitations in eHealth trials https://docs.

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 briesy explain why the item is not applicable/relevant for your study Your answer 21-ii) Discuss if there were elements in the RCT that would be diYerent in a routine application sejing 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. 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 briesy explain why the item is not applicable/relevant for your study

Your answer
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 briesy explain why the item is not applicable/relevant for your study "Trial Registration: Dutch trial register NTR6131, Registered on 20 October 2016." 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 briesy explain why the item is not applicable/relevant for your study "Dam AEH, de Vugt ME, van Boxtel MP, Verhey FR. Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial. Trials. 2017;18(1):395." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 25) Sources of funding and other suppoQ (such as supply of drugs), role of funders

X27) Conkicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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 briesy explain why the item is not applicable/relevant for your study "This study was supported in part by the Alzheimer Research Fund Limburg and ZonMw (70-73305-98-611)."

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (Pnancial 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 briesy explain why the item is not applicable/relevant for your study Your answer