Longitudinal Evaluation of an Integrated Post–COVID-19/Long COVID Management Program Consisting of Digital Interventions and Personal Support: Randomized Controlled Trial

Background The postacute COVID-19 syndrome (PACS) can be addressed with multidisciplinary approaches, including professional support and digital interventions. Objective This research aimed to test whether patients who received a health care facilitation program including medical internet support from human personal pilots and digital interventions (intervention group [IG] and active control group [ACG]) would experience fewer symptoms and have higher work ability and social participation than an untreated comparison group (CompG). The second objective was to compare the impact of a diagnostic assessment and digital interventions tailored to patients’ personal capacity (IG) with that of only personal support and digital interventions targeting the main symptoms (ACG). Methods In total, 1020 patients with PACS were recruited. Using a randomized controlled trial design between the IG and the ACG, as well as propensity score matching to include the CompG, analyses were run with logistic regression and hierarchical-linear models. Results Symptoms decreased significantly in all groups over time (βT1-T2=0.13, t549=5.67, P<.001; βT2-T4=0.06, t549=2.83, P=.01), with a main effect of the group (β=–.15, t549=–2.65, P=.01) and a more pronounced effect in the IG and ACG compared to the CompG (between groups: βT1-T2=0.14, t549=4.31, P<.001; βT2-T4=0.14, t549=4.57, P<.001). Work ability and social participation were lower in the CompG, but there was no significant interaction effect. There were no group differences between the IG and the ACG. Conclusions Empowerment through personal pilots and digital interventions reduces symptoms but does not increase work ability and social participation. More longitudinal research is needed to evaluate the effects of a diagnostic assessment. Social support and digital interventions should be incorporated to facilitate health care interventions for PACS. Trial Registration ClinicalTrials.gov NCT05238415; https://classic.clinicaltrials.gov/ct2/show/NCT05238415. International Registered Report Identifier (IRRID) RR2-10.1186/s12879-022-07584-z

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) #49342 TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title

1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Integrated Post-COVID-19/Long COVID Management Program Consisting of Digital Interventions and Personal Support" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Integrated Post-COVID-19/Long COVID Management Program Consisting of Digital Interventions and Personal Support"

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Post-COVID-19/Long COVID Management Program" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This research aimed to test whether patients who received a health care facilitation program including medical internet support from human personal pilots and digital interventions (intervention group [IG] and active control group [ACG]) would experience fewer symptoms and have higher work ability and social participation than an untreated comparison group (CompG). The second objective was to compare the impact of a diagnostic assessment and digital interventions tailored to patients' personal capacity (IG) with that of only personal support and digital interventions targeting the main symptoms (ACG). Methods: In total, 1020 patients with PACS were recruited. Using a randomized controlled trial design between the IG and the ACG, as well as propensity score matching to include the CompG, analyses were run with logistic regression and hierarchical-linear models" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 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. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Does your paper address subitem 1b-iii? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 1b-v?
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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) 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 brie y explain why the item is not applicable/relevant for your study "Despite good evidence that digital approaches targeting self-management of PACS can be effective, the programs that address PACS symptoms have rarely been evaluated. This includes their their long-term effectiveness in symptom reduction and work ability, especially in controlled research designs with a digital intervention platform augmented by human personal support and tailoring based on diagnostic assessments (...) We aimed to develop and evaluate an interdisciplinary health care facilitation program based on professional personal pilot support and digital interventions, both delivered as medical internet aid. The project in which the data for the study were collected included (1) online screening to diagnose PACS, (2) a human personal pilot concept that guided patients to recover, (3) a diagnostic assessment, and (4)  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Despite good evidence that digital approaches targeting self-management of PACS can be effective, the programs that address PACS symptoms have rarely been evaluated. This includes their their long-term effectiveness in symptom reduction and work ability, especially in controlled research designs with a digital intervention platform augmented by human personal support and tailoring based on diagnostic assessments" Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Overall, the project aimed to increase the self-management of patients with PACS to ensure their empowerment regarding their health care facilitation. (...) Hypothesis 1: Patients who receive support from personal pilots and digital interventions (IG and ACG) experience fewer symptoms after the program and have higher work ability and social participation than the untreated CompG. Hypothesis 2: For patients who receive a thorough diagnostic assessment and accordingly tailored digital interventions based on their personal capacity (IG), improvements regarding symptom reduction, social participation, and work ability will be larger than for patients who only receive the personal pilot and digital interventions targeting their main symptoms (ACG). Hypothesis 3: As previous research has shown that symptoms can negatively affect patients regarding their work ability, we hypothesized that symptom reduction over the course of the pandemic will be associated with higher work ability and social participation after the program." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In this partially randomized controlled trial, 3 groups of patients were recruited, including an IG, an ACG, and a care-as-usual CompG (which did not receive any specific treatment). (...) If the screening was positive, they were then admitted to the study program after randomization in a 1:2 ratio by the rolling of a die. Patients with a 1 or 2 on the die were allocated to the IG, while patients for whom the die showed 3-6 were randomized to the ACG." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study [Not applicable for this study, as no important changes to methods necessary]

3b-i) Bug fixes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].

4a) Eligibility criteria for participants
subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study "Personal pilots were available if patients needed any kind of support, for example, for technical support or if exercises did not fit their demands." No unexpected events happened and no major bugs needed to be fixed.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "• The participants had ≥3 (of 14) PACS symptoms with severity≥2 on a scale from 0 (no problem) to 3 (extreme problem).
• Symptoms could not be attributed to other causes by the participants. • Symptoms were new or exacerbated after a SARS-CoV-2 infection.
• The SARS-CoV-2 infection had been diagnosed more than 4 weeks ago.
• The participants had not fully or substantially recovered from their PACS symptoms.
• The participants suffered from impairments in their daily life. Additional inclusion criteria were that participants were between 18 and 60 years old, had not received previous treatment (eg, medical rehabilitation), and did not work in the health care sector, as that would have made them eligible for specialized treatment in Germany. Lastly, participants had no or only a low "care degree." "

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study "The IG and ACG were recruited via a separate online link exclusively in Bavaria through press releases, social media campaigns, and GPs who received flyers via mail and were asked to forward the information to their patients if they thought they might have PACS.
After reading the study information and providing consent to participate in the study, participants started with the initial screening." "After the screening and randomization, both the IG and the ACG were contacted by trained persons working in the project, who were called "personal pilots." The pilots evaluated the inclusion criteria in a first contact over the phone. This first contact was standardized to assess PACS symptoms, the timeline of the infection and development of PACS symptoms, potential previous treatment and management of the condition, and age, residency, and current employment. If any concerns arose regarding the eligibility of the patient, the personal pilots clarified with the research team and the patient. The pilots also provided more information about the study process during the first contact and organized the participation in the project."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 4b) Settings and locations where the data were collected subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Recruitment: "The IG and ACG were recruited via a separate online link exclusively in Bavaria through press releases, social media campaigns, and GPs who received flyers via mail and were asked to forward the information to their patients if they thought they might have PACS. Individuals in the CompG who answered not only the baseline questionnaires but also the repeated measures were included in the study. They were recruited online in Germany through social media campaigns and press releases." Assessments: All questionnaires were administered online. The personal pilots contacted their patients via phone. "The IG was invited to a 3-day inpatient assessment at a specialized neurological stationary rehabilitation clinic."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Outcomes were (self-)assessed through online questionnaires (as common in web-based trials) subitem not at all important Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-i?
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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?
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5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-iii?
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5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-v?
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5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "After enrollment and the first contact with their personal pilots, patients received access to the digital platform." The personal pilots set up an account for the patients and sent the access data via email. Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In the ACG, the personal pilots decided together with the patients which symptom-specific plan would be the most fitting. They could choose between digital interventions focusing on fatigue, neurocognitive symptoms, or cardiorespiratory symptoms. Patients in the IG received digital interventions based on their physiological and cognitive capacity that was determined during the assessment in the clinic. Digital intervention plans were developed specifically targeted for low, medium, and high capacity. Capacity was assessed both subjectively and objectively and finally summarized by a physician. (...) Contents of the digital interventions included breathing and relaxation exercises, mindfulness training, meditation, physical strength tasks, and sensory as well as functional training. All patients in the IG and ACG received personal guidance from their personal pilots and were encouraged to adapt the exercises individually, when needed. For this purpose, based on physiotherapeutic expertise, an exercise manual with different variants of the physical exercises was provided. The focus of the digital training was to strengthen the patients' selfmanagement. Patients took part individually in the asynchronous offers and were expected to adhere to the daily intervention plan. The time spent on the daily activities on average was 50.4 minutes (range 44.6-58.7, depending on the level of intensity) in the IG and 41.9 minutes (range 32.5-48.7) in the ACG."

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.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ix?
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5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The personal pilots could see whether a patient was completing their exercises. If the patients did not engage with the content for more than a few days, the pilots would remind them during the next phone call and provide support for any problems.

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Human Support and Personal Pilots: Trained professionals functioning as personal pilots had 2 main functions. First, they guided patients through the study process in a mainly synchronous but partially also asynchronous way over the phone and via email. Each patient was assigned a personal pilot who was available throughout their study participation. The pilots reminded the patients of the questionnaires, arranged the inpatient assessment in the IG, and provided recommendations and help for the asynchronous digital interventions. Second, the pilots empowered the patients in their individual approaches to cope with their PACS to enable them in finding the best-possible treatment. To achieve this, the pilots contacted all patients weekly in the beginning and biweekly during the digital interventions to reflect on the process, review the patients' needs, and work together on options for future care. The pilots also motivated the patients to identify and access further diagnostic and therapy options, as well as engage in activities of daily living, while pacing themselves to foster recovery. All pilots were either qualified psychologists, health scientists, or health care professionals (eg, physiotherapists) and were trained in motivational interviewing." subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Measures: To evaluate the ASAP project, the IG and ACG were compared with each other and with the CompG over time regarding primary and secondary outcomes. Outcomes included symptom severity (assessed at all time points), work ability (measured at T2, T4, and T5), and social participation (measured at T2, T4, and T5). Symptom severity was measured at all time points with a scale developed for the project [31]. In the screening and subsequent questionnaires, a list of 14 common PACS symptoms (eg, fatigue, muscle pain, respiratory problems) were listed. Patients indicated whether they suffered from the symptoms on a scale from 0 (no problem) to 3 (extreme problem). The sum of scores was calculated. Cronbach α was .80 at T1 across groups. Work ability was measured with a single item from the Work Ability Index (WAI) [35], namely "If you give your best-ever work ability a score of 10, how many points would you give your current work ability?" The answer options ranged from 0 (completely unable to work) to 10 (currently best work ability). Social participation was measured using a 12-item questionnaire [36] that assessed participants' ability to engage in specific activities (eg, taking care of one's health, eating healthy, exercising, or taking medication). Answer options ranged from0 (never) to 5 (always), and Cronbach α was .90 at T2 across groups." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable for the study, as trial outcomes were not changed. We focused the analyses of the current paper on symptom severity, work ability and social participation to not overwhelm readers. The full evaluation concept can be found in the study protocol under 10.1186/s12879-022-07584-z 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.
7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There were no interim analyses or stopping guidelines. The full sample was used for the evaluation.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "If the screening was positive, they were then admitted to the study program after randomization in a 1:2 ratio by the rolling of a die. Patients with a 1 or 2 on the die were allocated to the IG, while patients for whom the die showed 3-6 were randomized to the ACG." 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "If the screening was positive, they were then admitted to the study program after randomization in a 1:2 ratio by the rolling of a die. Patients with a 1 or 2 on the die were allocated to the IG, while patients for whom the die showed 3-6 were randomized to the ACG. In some cases, randomization was not possible (eg, if patients could not attend in-person interventions due to organizational reasons or were recruited after the assessment dates were booked). Thus, there was an exception for 30 (13.3%) patients who were reallocated to the ACG." Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "If the screening was positive, they were then admitted to the study program after randomization in a 1:2 ratio by the rolling of a die. Patients with a 1 or 2 on the die were allocated to the IG, while patients for whom the die showed 3-6 were randomized to the ACG." 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The first author of the study looked up the screening results, rolled the die and thus randomly assigned patients to the groups and thus in some cases to the diagnostic assessment. The digital interventions were assigned based on the diagnostic assessment, or in the ACG in a shared decision making process between personal pilots and patients.

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 cointerventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Patients were not blinded regarding the study groups in order to ensure full informed consent." Personal pilots administering co-interventions and study personnel was not blinded, but the data was analysed after anonymisation.
subitem not at all important 1 2 3 4 5 essential 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) 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 brie y explain why the item is not applicable/relevant for your study Meine Antwort 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 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Digital interventions had a different focus, but also similar aspects: "Contents of the digital interventions included breathing and relaxation exercises, mindfulness training, meditation, physical strength tasks, and sensory as well as functional training. All patients in the IG and ACG received personal guidance from their personal pilots and were encouraged to adapt the exercises individually, when needed. For this purpose, based on physiotherapeutic expertise, an exercise manual with different variants of the physical exercises was provided. The focus of the digital training was to strengthen the patients' self-management. Patients took part individually in the asynchronous offers and were expected to adhere to the daily intervention plan. The time spent on the daily activities on average was 50.4 minutes (range 44.6-58.7, depending on the level of intensity) in the IG and 41.9 minutes (range 32.5-48.7) in the ACG." Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All data analysis was conducted using RStudio version 4.1.2 (Posit). (...) For the first hypothesis, the IG and ACG were combined to reach a sufficient sample size and were compared with the CompG using hierarchical-linear models (HLMs). The logistic regression to compare groups was significant for age. To test the second hypothesis, the IG and the ACG were compared over time regarding their symptom severity from T1 to T5, in addition to work ability and social participation (both measured at T2, T4, and T5) using HLMs in R. (...) HLMs were conducted to compare the IG and the ACG without further control variables. For the HLMs, data were restructured to a long format using the gather function, and the HLMs were tested using lme, allowing for random intercepts. Random slopes could not be included in the HLMs, as there were not enough observations for the HLMs to converge." 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 attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Attrition was not high in the IG and ACG, thus, HLM could be used without implementation.
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "To evaluate the third and final hypothesis, 2 linear regression analyses were conducted to test whether a reduction in symptoms over time (T1-T4) predicted better work ability and social participation, respectively, at follow-up, controlled for age, sex, the BMI, and previous health conditions. To operationalize symptom reduction, a difference variable was calculated (mean symptom score at T4 -mean symptom score at T1)."

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons 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 brie y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study See flowchart, Figure 1 on page 5

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study Meine Antwort 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The item is not applicable/relevant for your study, as the trial was not 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 brie y explain why the item is not applicable/relevant for your study Please see Table 1, demographic data for baseline demographic and clinical characteristics for each group.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please see Table 1, demographic data for baseline demographic and clinical characteristics for each group.
As the screening was online, all participants had sufficient digital literacy and an internet connection to participate. The online screening might have kept participants with a lower digital literacy from participating in the first place, which might have contributed to digital divide issues.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Patients took part individually in the asynchronous offers and were expected to adhere to the daily intervention plan. The time spent on the daily activities on average was 50.4 minutes (range 44.6-58.7, depending on the level of intensity) in the IG and 41.9 minutes (range 32.5-48.7) in the ACG." Personal pilots helped the patients to complete their plans, so that patients were adherent to the plan of using the intervention daily over 6 weeks at any time of day.

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).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Testing Hypothesis 1: Intervention Effects Between the IG and the ACG vs the CompG: Comparing symptom severity across the time points T1, T2, and T4, we found a significant reduction in both the IG and the ACG over time (T1 vs T2: β=.13, t549=5.67, P<.001; T2 vs T4: β=.06, t549=2.83, P=.01). The main effect of the group was significant (β=-.15, t549=-2.65, P=.01), and the reduction in symptoms over time was more pronounced in the IG and ACG compared to the CompG (T1 vs T2 between groups: β=.14, t549=4.31, P<.001; T2 vs T4 between groups: β=.14, t549=4.57, P<.001). For work ability, there was no significant difference between T2 and T4, but the work ability was higher in the IG and ACG compared to the CompG (β=.78, t271=2.73, P=.01). Finally, social participation increased over time (β=.13, t277=1.98, P=.049) and was higher in the IG and ACG (β=.27, t277=2.89, P=.004), but there was no significant interaction effect. Figure  2 shows the development of symptom severity, work ability, and social participation over time. All statistics are reported in Table 4." "Testing Hypothesis 2: Intervention Effects Between the IG and the ACG: Concerning symptom severity, the HLM revealed a decrease over time in both the IG and the ACG but no group differences between the IG and the ACG. vs T5: β=-.34, t230=-2.59, P=.01), but no difference between the IG and the ACG was found. There were also no significant differences in social participation over time or between groups. Figure 3 shows the development of symptom severity, work ability, and social participation over time. All inference statistics are reported in Table 6." subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified 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 de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

Meine Antwort
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The item is not applicable/relevant for your study as we do not report binary outcomes.

19) All important harms or unintended effects in each group
(for speci c guidance see CONSORT for harms) Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Testing Hypothesis 3: Association Between Symptom Reduction, Work Ability, and Social Participation: Two linear regression analyses were conducted to test whether a reduction in symptoms between T1 and T4 had positive effects on patients' work ability and social participation. The analyses revealed that a greater reduction in symptoms does not predict a higher reported work ability when controlling for age, sex, the BMI, and previous health conditions (β=-.18, t111=-1.92, P=.06; R2 =0.32) but does predict a higher social participation (β=-.34, t111=-2.11, P=.04, R2 =0.24). All statistics are reported in Multimedia Appendix 2 (Tables A2 and A3)."

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The aim of this study was to develop and evaluate an interdisciplinary health care facilitation program based on professional support and digital interventions by increasing the self-management of patients with PACS. Within the ASAP project, the IG received a diagnostic assessment in a clinic, accordingly tailored digital interventions, and support from a human personal pilot. The ACG received the digital interventions and personal support but no assessment and no interventions tailored to the assessment results. Our first hypothesis was that both groups receiving interventions would benefit when compared to the passive CompG. Regarding symptom severity, there was a larger reduction in both the IG and the ACG compared to the CompG. Furthermore, work ability and social participation were higher in both treatment groups (IG and ACG). Our second hypothesis was that patients in the IG would benefit more than patients in the ACG as they received a diagnostic assessment that could potentially lead to more tailored treatment in the long run and also received a more tailored digital intervention program than patients in the ACG. However, based on the inferential statistics, this hypothesis failed to hold true. Both groups showed a similar level of symptom reduction and an increase in their work ability over time. Third, we hypothesized that patients' symptom reduction over the course of the intervention program would predict their work ability and social participation at follow-up. This was only the case for social participation but not work ability as the P value just failed to reach <.05."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort

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 brie y explain why the item is not applicable/relevant for your study Please refer to pages 15 and 16 in the manuscript for a detailed discussion of the limitations of this 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 subitem not at all important 1 2 3 4 5 essential OTHER INFORMATION 23) Registration number and name of trial registry Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 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 cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Meine Antwort 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study was registered at ClinicalTrials (ClinicalTrials ID: NCT05238415), and details have been published in the study protocol [31]." Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

Meine Antwort
As a result of using this checklist, did you make changes in your manuscript? * yes no Sonstiges: yes no Sonstiges: What were the most important changes you made as a result of using this checklist?

Meine Antwort
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * About 3 hours, but could not make any changes to manuscript as already accepted and edited As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary le.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you! Any other comments or questions on CONSORT EHEALTH The checklist took a long time to complete. There are 66 mandatory items in this form, which is too much. Some of the information (e.g. funding, trial registration) is part of the submission process anyway. I was asked to complete the checklist after the acceptance and copy-editing of the article, after providing a CONSORT sheet before. Simply copying and pasting text to answer questions does not improve a manuscript, especially since I could not make any changes anymore. Please make the eHEALTH checklist more practical. If the purpose is to improve manuscripts, the journal needs to make sure it is provided earlier.