Development and Initial Evaluation of the Web-Based Self-Management Program “Partner in Balance” for Family Caregivers of People With Early Stage Dementia: An Exploratory Mixed-Methods Study

Background People with dementia increasingly depend on informal caregivers. Internet-based self-management interventions hold considerable promise for meeting the educational and support needs of early stage dementia caregivers (EDCs) at a reduced cost. Objective This study aimed to (1) develop an online self-management program for EDC to increase self-efficacy and goal attainment, and (2) evaluate the program’s feasibility and report preliminary data on effectiveness. Methods Based on the Medical Research Council (MRC) framework for the development and evaluation of complex interventions, a stepwise approach was adopted to explore potential user needs and develop and validate the content by means of (1) focus group discussions with dementia caregivers (N=28), (2) interviews with dementia care professionals (N=11), and (3) individual think-aloud usability tests with EDC (N=2) and experts (N=2). A pilot evaluation was conducted with EDC (N=17) to test the feasibility and establish preliminary effects. Self-report measures of feasibility were completed after the completion of intervention. Self-efficacy and goal attainment were evaluated before and after the intervention. Results The different steps provided useful information about the needs of potential users regarding the content and delivery of the program. This resulted in the newly developed “Partner in Balance” program. At the start, system failures resulted in a high noncompleter rate (7/17, 41%), but at the end, an acceptable feasibility score of 209 (range 54-234) was found. The convenience of completing the program at home, the tailored content, and the guidance (face-to-face and online) were appraised positively. Preliminary effects on caregiver self-efficacy (P<.05) and goal attainment (T>50) were promising. Conclusions Adaptations were made to the program to limit the amount of system failures and prevent high noncompleter rates. As recommended by the MRC framework, confirming the feasibility and preliminary effectiveness is a valuable step toward examining the effectiveness of this newly developed intervention. Trial Registration Dutch Trial Register (NTR): NTR4217; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4217 (Archived by WebCite at http://www.webcitation.org/6f6B8lvRP).


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 brieoy explain why the item is not applicable/relevant for your study As this was a development study, the level of human involvement in the intervention is part of the results of this study: "Results: The convenience of completing the program at home, the tailored content and the guidance (face-to-face and online) were appraised positively."

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. ofoine), 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 ofoine 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 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 brieoy explain why the item is not applicable/relevant for your study "Methods: (1) focus group discussions with dementia caregivers (N=28), (2) interviews with dementia care professionals (N=11), and (3) individual think aloud usability tests with EDC (N=2) and experts (N=2). Furthermore, a pilot evaluation was conducted with EDC (N=17) to test the feasibility and establish preliminary effects. Results: The different steps provided useful information about the needs of potential users regarding the content and delivery of the program. This resulted in the newly developed 'Partner in Balance' program. At the start, system failures resulted in a high non-completer rate (41.2%), but at the end, a good feasibility score of 209 (range 54-234) was found. The convenience of completing the program at home, the tailored content and the guidance (face-to-face and online) were appraised positively. Preliminary effects on caregiver self-efficacy (P<0.05) and goal attainment (T>50) were promising."

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study INTRODUCTION 2a) In INTRODUCTION: ScientiUc background and explanation of rationale

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 standalone 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) 1 2 3 4 5 subitem not at all important 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 brieoy explain why the item is not applicable/relevant for your study this at-risk state, the transition into the caring role increases the need for effective caregiver interventions. Most caregiver interventions are face-to-face, but the expected gap between care supply and demand calls for alternative and cheaper ways to continue to provide education and support to informal caregivers [3,8]." Solution: "Internet interventions may help caregivers cope with the challenges of caring for a person with dementia [9]. In a recent literature review, currently available Internet interventions for dementia caregivers showed promising results on caregiver confidence and burden as long as they were comprised of multiple components and were tailored to the individual participant [10]. In addition, caregiver support offered through the Internet may prevent accessibility problems, as they may reach informal caregivers who are isolated or have difficulties accessing traditional healthcare services [11,12]." Particular population: "Early-stage interventions have the potential to prepare caregivers for their future tasks at a stage where stress and burden are relatively low [18]. Early intervention and support for caregivers has proven to be effective in reducing strain, increasing caregiver confidence, and delaying institutionalization of the person with dementia [19][20][21]. However, early-stage interventions may not be effective if they are not customized to the personal situation of the caregiver and the care recipient [18,22]. Online interventions that were not tailored to informal dementia caregivers showed no results on self-perceived stress or self-efficacy [23,24]. Early-stage dementia caregivers (EDC) find it difficult to identify with problem-oriented or stigmatizing information due to their struggle with acceptance and adaptation to their new caring role. Early therapeutic interventions may help caregivers identify their needs based on their individual situation and are aimed at facilitating the adaptation process [22]" Goals of the intervention: "The Stress and Coping paradigm by Lazarus and Folkman [25] and the Social Learning theory by Bandura [26] propose that taking charge of the changes in one's life promotes healthier behavior, increases self-efficacy and can therefore reduce caregiver stress and its impact on general wellbeing [27]. Following these theories, a support program for caregivers in the early stages of their caregiving role could be aimed at positively managing life with dementia rather than managing the dementia itself [28]. Selfmanagement programs suit the caring role transition and have previously been used to support informal caregivers of several chronic diseases with promising results [12,29,30]. The present study describes the development of an online self-management program for EDC to improve self-efficacy and goal attainment." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "In a recent literature review, currently available Internet interventions for dementia caregivers showed promising results on caregiver confidence and burden as long as they were comprised of multiple components and were tailored to the individual participant [10]. In addition, caregiver support offered through the Internet may prevent accessibility problems, as they may reach informal caregivers who are isolated or have difficulties accessing traditional healthcare services [11,12]."

2a-ii) Scienti/c background, rationale: What is known about the (type of) system
"Early intervention and support for caregivers has proven to be effective in reducing strain, increasing caregiver confidence, and delaying institutionalization of the person with dementia [19][20][21]. Earlystage interventions may not be effective if they are not customized to the personal situation of the caregiver and the care recipient [18,22]. Online interventions that were not tailored to informal dementia caregivers showed no results on self-perceived stress or self-efficacy [23,24]." "Self-management programs suit the caring role transition and have previously been used to support informal caregivers of several chronic diseases with promising results [12,29,30]."

2b) In INTRODUCTION: SpeciUc objectives or hypotheses
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 brieoy explain why the item is not applicable/relevant for your study "The present study describes the development of an online selfmanagement program for EDC to improve self-efficacy and goal attainment following the iterative process of the new Medical Research Counsel (MRC) Framework for the development of complex interventions [31]. The first two steps in the intervention development are described elsewhere, namely a thorough literature review [10] and exploration of caregiver needs [22]. The current paper will describe the next steps: designing the intervention content and structure, testing the feasibility and the preliminary effects of the online intervention on caregiver self-efficacy and goal attainment and adapting the intervention accordingly. This resulted in the intervention 'Partner in Balance'." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 brieoy explain why the item is not applicable/relevant for your study This development study consists of different steps. "To evaluate the feasibility of the program, we conducted an uncontrolled pre-post-intervention pilot study with EDC." 3b) Important changes to methods after trial https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4lE…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full commencement (such as eligibility criteria), with reasons 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 brieoy explain why the item is not applicable/relevant for your study "In this study the program was evaluated with a homogenous group of primary caregivers (e.g. spousal caregivers), as specific aspects of the program were aimed at the spousal relationship. However, the themes may apply to a broader target group, as demonstrated by previous studies [13][14][15][16][17]. Partner in Balance could potentially be suitable for other primary carers, which should be further investigated in the upcoming effect study using a larger sample."

3b-i) Bug /xes, 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 inouenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "Based on the PPQ item scores and additional comments, some adaptations were made to the program to increase user-friendliness. As described above, we adapted features with lower item scores or with negative comments, including the discussion forum, practical decisions and video clips. We adapted the discussion forum by adding regular posts from personal coaches with practical tips, literature and events related to EDC. The video clips were adapted to clarify the role and background of the person in the video. Additionally, we expanded the content on often-mentioned early-stage situations and problems [22] and made later-stage problems less prominent in the video clips. Furthermore, technical issues with logging in and communicating with the personal coach were resolved with the team of web experts. The final intervention is described in Multimedia Appendix 2."

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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Internet, were willing to participate, and if they were spousal caregivers of people with Mild Cognitive Impairment (MCI) [39] or mild dementia of all subtypes as described in the Diagnostic and Statistical Manual of Mental Disorders [40]. Caregivers were excluded if they had insufficient cognitive abilities to engage in the online selfmanagement program, were overburdened or had severe health problems as determined by study staff, or cared for PwD caused by human immunodeficiency virus, acquired brain impairment, Down syndrome, Huntington's chorea, or alcohol abuse"

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 brieoy explain why the item is not applicable/relevant for your study "if they had access to the Internet" was one of the inclusion criteria. However, we experienced that some experience with computers and Internet is necessary.
"The unfamiliarity with the use of the website also caused difficulties among the older age group, resulting in a relatively young sample. A recent study confirmed that younger dementia caregivers were more likely to use the Internet for health-related purposes [67]. However, previous research has shown that with the help of computer training at the start of an intervention, homebound older adults with limited computer skills are able to participate without difficulties [68]." 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. ofoine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email 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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "Participants were recruited via the Memory Clinic of the Academic Hospital Maastricht, Alzheimer Cafes and the Elderly Division of the community mental health organization Virenze-RIAGG Maastricht." "Feasibility information was collected face-to-face at the caregiver's home by a retrospective semi-structured interview developed for this study, the Program Participation Questionnaire (PPQ)." "Partner in Balance consists of 3 elements: (1) face-to-face intake session with a personal coach, (2) online period guided by the personal coach, and (3) face-to-face evaluation session with the personal coach."

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 brieoy explain why the item is not applicable/relevant for your study "A total of 43 caregivers were contacted and sent a detailed information letter about the study and a form requesting their informed consent based on an expected response rate of 27% [43]. Of those contacted, 17 (40%) were willing to participate and signed the informed consent." 4b) Settings and locations where the data were collected 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 brieoy explain why the item is not applicable/relevant for your study "Feasibility information was collected face-to-face at the caregiver's home by a retrospective semi-structured interview developed for this study, the Program Participation Questionnaire (PPQ)." "Preliminary understanding of the effectiveness of the program was collected by pre-and post-intervention paper questionnaires completed at participant's own convenience during one week from the postintervention assessment."
1 2 3 4 5 subitem not 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 brieoy explain why the item is not applicable/relevant for your study "Feasibility information was collected face-to-face at the caregiver's home by a retrospective semi-structured interview developed for this study, the Program Participation Questionnaire (PPQ)." "Preliminary understanding of the effectiveness of the program was collected by pre-and post-intervention paper questionnaires completed at participant's own convenience during one week from the postintervention assessment."

4b-ii) Report how institutional af/liations are displayed
Report how institutional afUliations are displayed to potential participants [on ehealth media], as afUliations 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) 1 2 3 4 5 subitem not at all important essential

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 brieoy explain why the item is not applicable/relevant for your study Maastricht University is displayed on the homepage of the course website, as the course is currently being evaluated within a scientific study "A homepage with a short description of the goal of the program, personal login option, contact information of the researcher and the institutional affiliation (Maastricht University)." "The course is currently (November 2015) available for caregivers that are interested in participating in the effectiveness study. At the course website (www.partnerinbalans.nl) they can express their interest by emailing the researcher, after which they will receive additional information about the course and the effectiveness study." 5) The interventions for each group with sufUcient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, af/liations of the developers, sponsors, and owners
Mention names, credential, afUliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conoict of interest" section or mentioned elsewhere in the manuscript). https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 1 2 3 4 5 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 brieoy explain why the item is not applicable/relevant for your study "This study is part of a larger study funded by Alzheimer Nederland (Grant no. WE03-2010-08), and the Alzheimer Research Fund Limburg."

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study This entire paper is the history/development process: "In this paper the iterative development process of the web-based self-management program 'Partner in Balance' (PiB) for EDC was presented. Use of the MRC framework enabled us to develop an intervention based on existing research, theoretical frameworks, and user and professional input. Including potential users during the design process enabled us to gain unique insights into usage behavior and challenges and to adapt the technology to the needs of the target audience."

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).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "Taking the existing evidence and personal needs of caregivers as a starting point, the study consisted of four steps spread over a 2-year time period (2012-2014): (1) explore potential user views; (2) develop and validate the content and structure of the online program; (3) test the feasibility and the preliminary effectiveness; and (4) adapt the program based on the feasibility findings." "The course is currently (November 2015) available for caregivers that are interested in participating in the effectiveness study. At the course website (www.partnerinbalans.nl) they can express their interest by emailing the researcher, after which they will receive additional information about the course and the effectiveness 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 brieoy explain why the item is not applicable/relevant for your study Including potential users during the design process enabled us to gain unique insights into usage behavior and challenges and to adapt the technology to the needs of the target audience. A similar design has been successfully used in previous studies [53][54][55].
"Based on the Medical Research Counsel (MRC) framework for the development and evaluation of complex interventions, the study used a stepwise approach to explore potential user needs and develop and validate the content by means of (1) focus group discussions with dementia caregivers (N=28), (2) interviews with dementia care professionals (N=11), and (3) individual think aloud usability tests with EDC (N=2) and experts (N=2)."

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 oowcharts 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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full A screenshot of the website was included, but peer-reviewers pointed out that the screenshot was not interesting for JMIR readers as it was in Dutch. However, a clear description of the website structure, content and modules was provided in the Multimedia Appendix II.

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 brieoy explain why the item is not applicable/relevant for your study "The course is currently (November 2015) available for caregivers that are interested in participating in the effectiveness study. At the course website (www.partnerinbalans.nl) they can express their interest by emailing the researcher, after which they will receive additional information about the course and the effectiveness 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).
1 2 3 4 5 subitem not at 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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full informed consent. They were subsequently scheduled for the baseline and post-intervention assessment 8 weeks later and were given access to the program." "The course is currently (November 2015) available for caregivers that are interested in participating in the effectiveness study. At the course website (www.partnerinbalans.nl) they can express their interest by emailing the researcher, after which they will receive additional information about the course and the effectiveness study." Caregivers' responses to their stress situation might be mediated by their understanding of the situation and their beliefs about their ability to cope. The latter fits Bandura's [26] concept of self-efficacy. Selfefficacy is defined as a person's belief that he or she can perform a specific action in a particular situation. Consistent with this theory, models of dementia management emphasize the need to maintain self-worth and control [28]. An intervention aimed at increasing selfefficacy (belief in one's capabilities) should not only educate the caregiver, but should foster self-management by combining education with problem-solving skills, and work towards a change in behavior [36]."

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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "Based on the discussed areas for improvement, participants select 4 modules of the 9 presented modules earlier identified by experts and caregivers. For every module, two weeks are reserved as a starting point. However, participants are allowed to complete the modules at their own pace as informed by the self-management approach [49]. The first week of a module is set aside for the video-clip, the introduction, the self-reflective assignment and the 5-stepplan. Participants send their assignment and 5-stepplan to their coach. The second week of every module is reserved for feedback from the coach, after which participants can adjust their 5-stepplan if necessary." "The actual accessed data use of the program, including how many times participants logged in and which features they used, were compared to self-report data." "Self-report data on the usage of the program were comparable to the tracked data usage; 106.41 (SD 96.15) minutes were spent per module, including scoping the website (4.4 minutes, SD 4.13), completing the assignments and change plan (79.14 minutes, SD 77.16), contacting the personal coach (15.31, SD 16.96) and visiting the discussion forum, spread out over 2.38 (SD 1.38) weeks"

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "(1) face-to-face intake session with a personal coach, (2) online period guided by the personal coach, and (3) face-to-face evaluation session with the personal coach." "Participants send their assignment and 5-stepplan to their coach. The second week of every module is reserved for feedback from the coach, after which participants can adjust their 5-stepplan if necessary." "Feasibility information was collected face-to-face at the caregiver's home by a retrospective semi-structured interview developed for this study, the Program Participation Questionnaire (PPQ)."

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).
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "...guided by the personal coach who will provide individualized feedback online after each module and offer assistance when needed."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as standalone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.
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 brieoy explain why the item is not applicable/relevant for your study not applicable in this study, no co-interventions were applied for the early-stage dementia caregivers 6a) Completely deUned pre-speciUed primary and secondary outcome measures, including how and when they were assessed 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 brieoy explain why the item is not applicable/relevant for your study "It is recommended to establish feasibility before moving on to a larger scale effect study [31,46]. As there were no external criteria to define the program's feasibility, we followed the conventional strategy of using the median score. This approach was previously adopted in a Delphi study as evidence of agreement of intervention feasibility [47]. Based on the scale used (range 54-234, median 144), scores of 145 or higher were viewed as good feasibility." "Preliminary understanding of the effectiveness of the program was collected by pre-and post-intervention paper questionnaires completed at participant's own convenience during one week from the post-intervention assessment. The Caregiver Self-Efficacy Scale (CSES) was used to measure domain-specific caregiver self-efficacy. The subscales of the CSES are based on a Dutch version [44] of the self-efficacy instrument of Lorig and colleagues [48] and included four items on service use and six items on care management, with scores ranging from 1 (not at all certain) to 10 (very certain). In the current study, a good internal consistency was demonstrated for both service use (α=0.73) and care management (α=0.87). Paired samples t-tests were conducted to evaluate pre-post intervention changes. The Goal Attainment Scaling (GAS) [49] method was used to rate treatmentrelated change and to compare relative success of previously set personal goals. Because personal goals within self-care can differ, GAS is a suitable measure to translate goals into achievement ratings. The scores range from -2 (much less than expected) to +2 (much better than expected), with a score of 0 meaning that the goal was attained. Raw scores were transformed into an individual mean GAS score (T-score) to determine goal attainment [50]. T-scores included attainment level and a potential weight assigned to the goal(s). T-scores of ≥ 50 indicate effective goal achievement." https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 [9].

Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text not applicable, paper questionnaires were used

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de/ned/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was 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 "Furthermore, the actual accessed data use of the program, including how many times participants logged in and which features they used, were compared to self-report data." "Self-report data on the usage of the program were comparable to the tracked data usage; 106.41 (SD 96.15) minutes were spent per module, including scoping the website (4.4 minutes, SD 4.13), completing the assignments and change plan (79.14 minutes, SD 77.16), contacting the personal coach (15.31, SD 16.96) and visiting the discussion forum, spread out over 2.38 (SD 1.38) weeks."

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). Copy and paste relevant sections from manuscript text Qualitative feedback was requested during every step in this development article: "(1) focus group discussions with dementia caregivers (N=28), (2) interviews with dementia care professionals (N=11), and (3) individual think aloud usability tests with EDC (N=2) and experts (N=2). Furthermore, a pilot evaluation was conducted with EDC (N=17) to test the feasibility (semi-structured interview)" 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 brieoy explain why the item is not applicable/relevant for your study No changes were made as the outcomes were predefined 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 brieoy explain why the item is not applicable/relevant for your study "Based on comparable studies evaluating the feasibility of online interventions for dementia caregivers, we aimed to include ten participants [41,42]. A total of 43 caregivers were contacted and sent a detailed information letter about the study and a form requesting their informed consent based on an expected response rate of 27% [43]. Of those contacted, 17 (40%) were willing to participate and signed the informed consent." 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 brieoy explain why the item is not applicable/relevant for your study Not applicable during this development study 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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 brieoy explain why the item is not applicable/relevant for your study Not applicable during this development study (not a randomized controlled trial) 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 https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Not applicable during this development study (not a randomized controlled trial) 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 brieoy explain why the item is not applicable/relevant for your study Not applicable during this development study (not a randomized controlled trial) 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 brieoy explain why the item is not applicable/relevant for your study Not applicable during this development study (not a randomized controlled trial) https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment 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).
1 2 3 4 5 subitem not at all important essential 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 brieoy explain why the item is not applicable/relevant for your study Not applicable during this development study (not a randomized controlled trial)

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 brieoy explain why the item is not applicable/relevant for your study Not applicable during this development study (not a randomized controlled trial) https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=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)

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 brieoy explain why the item is not applicable/relevant for your study Not applicable during this development study (not a randomized controlled trial) 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 brieoy explain why the item is not applicable/relevant for your study Not a randomized controlled trial comparing groups.
"Correcting for mirrored items, mean scores were calculated by means of descriptive statistics" "Paired samples t-tests were conducted to evaluate pre-post intervention changes. The Goal Attainment Scaling (GAS) [49] method was used to rate treatment-related change and to compare relative success of previously set personal goals. Because personal goals within self-care can differ, GAS is a suitable measure to translate goals into achievement ratings. The scores range from -2 (much less than expected) to +2 (much better than expected), with a score of 0 meaning that the goal was attained. Raw scores were transformed into an individual mean GAS score (T-score) to determine goal attainment [50]. T-scores included attainment level and a potential weight assigned to the goal(s). T-scores of ≥ 50 indicate effective goal achievement."

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 https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "The study population consisted of 17 participants, of whom ten completed the post-intervention assessment. Participants who did not complete the post-intervention assessment were replaced to still meet the sample size suggested by previous studies [41,42]." 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 brieoy 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 ofoine 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 brieoy explain why the item is not applicable/relevant for your study "A total of 43 caregivers were contacted and sent a detailed information letter about the study and a form requesting their informed consent based on an expected response rate of 27% [43]. Of those contacted, 17 (40%) were willing to participate and signed the informed consent. They were subsequently scheduled for the baseline and post-intervention assessment 8 weeks later and were given access to the program."

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 brieoy explain why the item is not applicable/relevant for your study "Participants will be provided with personal login codes to access their selected modules and edit their personal information" "help-button" "guided by the personal coach who will provide individualized feedback online after each module and offer assistance when needed." "-Personal page with a link to the chosen modules and a mailbox https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full

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 brieoy explain why the item is not applicable/relevant for your study Not applicable, not a randomized controlled trial "The study population consisted of 17 participants, of whom ten completed the post-intervention assessment. Participants who did not complete the post-intervention assessment were replaced to still meet the sample size suggested by previous studies [41,42]." 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ]ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study Not a randomized controlled trial, no flow diagram "The study population consisted of 17 participants, of whom ten completed the post-intervention assessment. Participants who did not complete the post-intervention assessment were replaced to still meet the sample size suggested by previous studies [41,42]. The main reasons for not completing the program and the post-intervention assessment were difficulties with the online aspect of the program (N=4), private circumstances apart from the intervention (N=2), and disagreements with the care recipient (N=1). Completer and noncompleter characteristics are listed in Table 3. No significant differences were reported between the groups, but the noncompleters reported higher hours of care per week compared to the completers of the program."

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Ugures or tables demonstrating usage/dose/engagement. 1 2 3 4 5 subitem not at all important essential https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Does your paper address subitem 13b-i?
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 brieoy explain why the item is not applicable/relevant for your study Not a randomized controlled trial, following this development study this item will be evaluated in an effectiveness study 14a) Dates deUning the periods of recruitment and follow-up 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 brieoy explain why the item is not applicable/relevant for your study "Taking the existing evidence and personal needs of caregivers as a starting point, the study consisted of four steps spread over a 2-year time period (2012-2014): (1) explore potential user views; (2) develop and validate the content and structure of the online program; (3) test the feasibility and the preliminary effectiveness; and (4) adapt the program based on the feasibility findings"

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

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 brieoy explain why the item is not applicable/relevant for your study Not applicable https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 14b) Why the trial ended or was stopped (early) 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 brieoy 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 group 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 brieoy explain why the item is not applicable/relevant for your study No randomized controlled trial, only one group "Completer and non-completer characteristics are listed in Table 3. No significant differences were reported between the groups, but the noncompleters reported higher hours of care per week compared to the completers of the program." "personal coach (psychologist or psychiatric nurse with ample experience with dementia caregivers),"

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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Table 3 reports on age caregiver, care recipient, hours of care per week, gender, education, and care recipient diagnosis.
"No significant differences were reported between the groups, but the non-completers reported higher hours of care per week compared to the completers of the program." 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 de/nitions
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 brieoy explain why the item is not applicable/relevant for your study "Post-intervention, participants (N=10) had higher scores on both CSES care management subscale (M=41.1, SE=2.5) and service use subscale (M=32.6, SE=1.7) compared to pre-intervention (M=36.1, SE=3.2 and M=23.2, SE=3.4, respectively). These differences were significant (care management: t(9) =-2.5, P=.03, service use: t(9) =-3.5, P=.01). However, effect sizes were small for both care management (d=0.14) and service use (d=0.41)."

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 brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "The high non-completer rate led to no available post-test data from the non-completers because these data were collected after the last module. However, reasons for noncompletion and characteristics of noncompleters were provided, giving insight into their possible motives. Future effectiveness studies should include non-completer data at posttreatment and follow-up" 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 brieoy explain why the item is not applicable/relevant for your study "The Program Participation Questionnaire (PPQ) showed a good internal consistency (α=0.89). A mean sum score of 209 (SD 22.14) was found on the PPQ. Given the threshold of 145 or higher, this score indicated an acceptable feasibility." "Post-intervention, participants (N=10) had higher scores on both CSES care management subscale (M=41.1, SE=2.5) and service use subscale (M=32.6, SE=1.7) compared to pre-intervention (M=36.1, SE=3.2 and M=23.2, SE=3.4, respectively). These differences were significant (care management: t(9) =-2.5, P=.03, service use: t(9) =-3.5, P=.01). However, effect sizes were small for both care management (d=0.14) and service use (d=0.41)." "Eight program completers set 13 goals in total. Two program completers were not able to set goals due to personal difficulties verbalizing the desired change. The mean number of set goals was 1.6, ranging from 1 to 4. The mean T-score at baseline was 27.8 (SD 3.04). The mean achieved T-score at post-intervention was 53.7 (SD 12.03). Table 5 shows the number of goals for each domain in which goals were set. Most goals were set on communication with the care recipient, followed by maintaining positive activities together, obtaining social support and planning time alone."

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 brieoy 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 brieoy explain why the item is not applicable/relevant for your study "Technical problems: login and communication" "Technical issues with logging in and communicating with the personal coach were resolved with the team of web experts"

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 brieoy explain why the item is not applicable/relevant for your study "Positive, negative and neutral themes derived from the additional comments are summarized and illustrated with quotes in Table 4" 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)
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-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 brieoy explain why the item is not applicable/relevant for your study "In this study the program was evaluated with a homogenous group of primary caregivers (e.g. spousal caregivers), as specific aspects of the program were aimed at the spousal relationship. However, the themes may apply to a broader target group, as demonstrated by previous studies [13][14][15][16][17]. PiB could potentially be suitable for other primary carers, which should be further investigated in the upcoming effect study using a larger sample." "Future research should consider also including caregivers in the proposed content validation, to ensure potential user feedback in every step of the development." "Future effectiveness studies should include non-completer data at post-treatment and follow-up. " 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full was high, as the content and adaptations were based on in-depth participant and expert feedback. Furthermore, seniors' use of the Internet is expected to increase over time [72], but to date, dementia caregivers seem to be less active in health-related Internet use compared to the population at large [67]. Furthermore, the high noncompleter rate led to no available post-test data from the noncompleters because these data were collected after the last module. However, reasons for noncompletion and characteristics of noncompleters were provided, giving insight into their possible motives." 21) Generalisability (external validity, applicability) of the trial Undings NPT: External validity of the trial Undings according to the intervention, comparators, patients, and care providers or centers involved in the trial

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 1 2 3 4 5 subitem not at all important essential

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 brieoy explain why the item is not applicable/relevant for your study "Due to the small sample size, the lack of a control condition and a possible sampling bias based on caregivers with access to the Internet, it is difficult to generalize the results. However, the level of user and expert involvement in the development of the intervention was high, as the content and adaptations were based on in-depth participant and expert feedback."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brieoy explain why the item is not applicable/relevant for your study "If proven effective, blended care interventions could be more easily adopted by health services, therapists and clients than online therapy, as they can be integrated in existing treatment and care settings [61]."

23) Registration number and name of trial registry
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 brieoy explain why the item is not applicable/relevant for your study Not a randomized controlled trial "Dutch Trial Register (NTR): NTR4217" 24) Where the full trial protocol can be accessed, if available 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 brieoy explain why the item is not applicable/relevant for your study Not applicable, the RCT trial protocol is currently in preparation 25) Sources of funding and other support (such as supply of drugs), role of funders https://docs.google.com/forms/d/1KlxFl4iTrxRIWADX-jCukJwHv4l…?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 brieoy explain why the item is not applicable/relevant for your study "This study is part of a larger study funded by Alzheimer Nederland (Grant no. WE03-2010-08), and the Alzheimer Research Fund Limburg."

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (Unancial 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 brieoy explain why the item is not applicable/relevant for your study "None declared."

About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?