Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study

Background Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population. Objective This randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care. Methods A pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences. Results A total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF. Conclusions We recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care. Trial Registration ClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 International Registered Report Identifier (IRRID) RR2-10.2196/resprot.8367


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 offline 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study "Challenges of Telemonitoring Programs for Complex Chronic Conditions: A Randomized Controlled Trial with an Embedded Qualitative Study" The term program was intentionally used in the manuscript title to encompass the clinical decision support and self-care components of telemonitoring interventions.

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Challenges of Telemonitoring Programs for Complex Chronic Conditions: A Randomized Controlled Trial with an Embedded Qualitative Study" 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 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 briefly explain why the item is not applicable/relevant for your study "Participants were randomized into the control and telemonitoring groups with the latter being instructed to take readings relevant to their condition(s). The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs."

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 11/57 subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs." 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. offline), 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 offline 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) 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 briefly explain why the item is not applicable/relevant for your study "A pragmatic, unblinded, 6-month RCT sought to recruit 146 patients with a diagnosis of heart failure (HF), uncontrolled hypertension (HT), and/or insulin requiring diabetes (DM) from outpatient specialty settings in Toronto, Canada." 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 briefly explain why the item is not applicable/relevant for your study "The primary outcome was health status as measured by the SF-36. Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and selfreported healthcare utilization. HF-related quality of life and self-care measures were also collected from patients followed for HF." "A total of 96 patients were recruited and randomized. Recruitment was terminated early due to implementation challenges and the onset of COVID-19." 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. 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 briefly explain why the item is not applicable/relevant for your study "Opinions expressed by the 5 HCPs and 13 patients interviewed differed based on the condition(s) monitored. Although HF patients reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care, and the design of the decision support whereby it was indicated that fluctuations in HT and DM patient status typically required less urgent intervention compared to HF." "Consistent with previous studies, we recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary, but not sufficient components of such programs for complex patients with lower acuity. We conclude that a multidisciplinary model of care that includes care coordination must accompany telemonitoring systems which may best be operationalized through novel models of care such as nurse-led models "

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) Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Although research on telemonitoring is rapidly growing [11], these systems typically target a singular condition such as diabetes mellitus (DM), hypertension (HT), or heart failure (HF) [12][13][14]. Systematic reviews indicate that telemonitoring for single conditions lead to improved health outcomes and quality of life, as well as reductions in healthcare utilization and costs [15][16][17][18][19][20][21]. Studies that do not report improvements often did not include a self-care component, were difficult to use, or did not target the most ill and frequently hospitalized patients [22][23][24][25]. To date, few studies have focused on the use of telemonitoring among complex patients, even though these patients may benefit the most from such interventions [15,[26][27][28][29][30][31][32]." 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 briefly explain why the item is not applicable/relevant for your study "The objective of this study was to evaluate the impact of a mobile phone-based telemonitoring program for the management of complex patients in specialty care settings. Complex patients were defined as those who are at high risk for hospitalization, exacerbations of their chronic conditions, and disease progression, as well as patients with MCCs, including HF, uncontrolled HT, and insulin-requiring DM. The primary research question was: What is the impact of a telemonitoring program for complex patients on health status, self-management, and health service utilization? The secondary research question was: What were the experiences of patients and HCPs related to the telemonitoring program and the way in which it was implemented?" 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This was a pragmatic, unblinded, 1:1 randomized control trial (RCT) comparing the 6-month impact of telemonitoring to support the management of patients with complex conditions to the standard of care." 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 briefly explain why the item is not applicable/relevant for your study "Although the intent was for patients with MCCs to be followed holistically, development delays for the HT and DM modules led to HF patients being enrolled and managed for HF alone, even if they had MCCs. In addition, the siloed nature of specialty care made it such that even when the technology could support the simultaneous management of HF, DM, and HT, patients were only monitored for the condition being managed at the location of enrollment. As a result, the model of care differed depending on the structure and resources at each clinic. For example, alerts for HF patients were primarily addressed by nurse practitioners who would escalate issues to the treating cardiologist as required. In contrast, telemonitoring alert management for HT and DM was the responsibility of the treating physician." 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 briefly explain why the item is not applicable/relevant for your study "Although the intent was for patients with MCCs to be followed holistically, development delays for the HT and DM modules led to HF patients being enrolled and managed for HF alone, even if they had MCCs. In addition, the siloed nature of specialty care made it such that even when the technology could support the simultaneous management of HF, DM, and HT, patients were only monitored for the condition being managed at the location of enrollment. As a result, the model of care differed depending on the structure and resources at each clinic. For example, alerts for HF patients were primarily addressed by nurse practitioners who would escalate issues to the treating cardiologist as required. In contrast, telemonitoring alert management for HT and DM was the responsibility of the treating physician." 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 briefly explain why the item is not applicable/relevant for your study "To be eligible, patients had to be 18 years of age or older, able to speak and read English (or have a caregiver who does), and diagnosed with HF with reduced ejection fraction (EF<40 percent), uncontrolled HT (≥140/90 mmHg auscultatory), or insulin-requiring DM and performing self-capillary glucose monitoring. Exclusion criteria included being on mechanical circulatory support, dialysis, or on the transplant list. In addition, patients with a life expectancy less than 1 year, dementia, uncontrolled psychiatric illness, or residents of a long-term care facility were excluded. See the published protocol for full criteria [33]."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
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 briefly explain why the item is not applicable/relevant for your study Computer / internet literacy was not an eligibility criterion. 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. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients with HF were recruited from the Heart Function Clinic at the University Health Network (

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.

4b) Settings and locations where the data were collected
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 briefly explain why the item is not applicable/relevant for your study "Patients with HF were instructed to monitor daily weight, blood pressure, heart rate, and symptoms. Due to the frequency of readings and higher complexity of the HF Medly algorithm [36], patient feedback was designed to be highly actionable. For example, patients were told to take a dose of their prescribed diuretic and restrict salts and fluids upon a large weight gain. Patients with DM were instructed to record blood glucose readings at least once per week or more as instructed by their HCP and received actionable feedback (e.g., "Eat 15g (1 tbls) of sugar or other fast-acting carbohydrates" in response to low blood glucose readings). Patients with HT were instructed to report their blood pressure once every two weeks unless the readings were out of range, in which case, they would be instructed through the app to increase the frequency of their readings. All modules had messages instructing users to contact the clinic or to go to the emergency department when critical parameters were out of range. To assist with adherence, an automated phone call was sent to patients based on the required frequency of each condition's algorithm." 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 briefly explain why the item is not applicable/relevant for your study "This was a pragmatic, unblinded, 1:1 randomized control trial (RCT) comparing the 6-month impact of telemonitoring to support the management of patients with complex conditions to the standard of care. 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 briefly explain why the item is not applicable/relevant for your study Outcomes were not self-assessed through online questionnaires 4b-ii) Report how institutional affiliations are displayed Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results)

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "ES, HR, JC are considered inventors of the Medly system under the intellectual property policies of the UHN and may benefit from future commercialization of the technology by UHN."

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. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The intervention was a mobile phone-based telemonitoring program involving a system, named Medly, which enables patients with chronic conditions to take relevant physiological measurements with wireless home medical devices and to answer symptom questions using the Medly smartphone app. In response to these inputs, rule-based algorithms which were iteratively developed and validated by HF, DM, and HT specialists [34] and customized through target thresholds, displayed self-care instructions to patients ( Figure 1) and sent alerts to the clinical team via email and a secure web portal where historical trends could also be viewed [34]. As such, the system was designed to improve patient self-management and provide clinical decision support to HCPs [35]."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.
Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study N/A -No revisions were made to the application during the evaluation process.

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 briefly explain why the item is not applicable/relevant for your study Your answer 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific 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 briefly explain why the item is not applicable/relevant for your study "In response to these inputs, rule-based algorithms which were iteratively developed and validated by HF, DM, and HT specialists [34] and customized through target thresholds, displayed self-care instructions to patients ( Figure 1)

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 briefly explain why the item is not applicable/relevant for your study The Medly system is available by prescription only and is not available to the public. Screenshots of the intervention have been provided in Figure 1.

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 specific 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). subitem not at all important 1 2 3 4 5 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 briefly explain why the item is not applicable/relevant for your study "The intervention was a mobile phone-based telemonitoring program involving a system, named Medly, which enables patients with chronic conditions to take relevant physiological measurements with wireless home medical devices and to answer symptom questions using the Medly smartphone app. In response to these inputs, rule-based algorithms which were iteratively developed and validated by HF, DM, and HT specialists [34] and customized through target thresholds, displayed self-care instructions to patients ( Figure 1) and sent alerts to the clinical team via email and a secure web portal where historical trends could also be viewed [34]. As such, the system was designed to improve patient self-management and provide clinical decision support to HCPs [35]. Participants were provided with the necessary equipment, including a smartphone and relevant Bluetooth devices (weight scale, blood pressure monitoring, blood glucose monitor) [33]." 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 briefly explain why the item is not applicable/relevant for your study "The intervention was a mobile phone-based telemonitoring program involving a system, named Medly, which enables patients with chronic conditions to take relevant physiological measurements with wireless home medical devices and to answer symptom questions using the Medly smartphone app. In response to these inputs, rule-based algorithms which were iteratively developed and validated by HF, DM, and HT specialists [34] and customized through target thresholds, displayed self-care instructions to patients ( Figure 1) and sent alerts to the clinical team via email and a secure web portal where historical trends could also be viewed [34]. As such, the system was designed to improve patient self-management and provide clinical decision support to HCPs [35]. Participants were provided with the necessary equipment, including a smartphone and relevant Bluetooth devices (weight scale, blood pressure monitoring, blood glucose monitor) [33]."

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 briefly explain why the item is not applicable/relevant for your study "Patients with DM were instructed to record blood glucose readings at least once per week or more as instructed by their HCP and received actionable feedback (e.g., "Eat 15g (1 tbls) of sugar or other fast-acting carbohydrates" in response to low blood glucose readings). Patients with HT were instructed to report their blood pressure once every two weeks unless the readings were out of range, in which case, they would be instructed through the app to increase the frequency of their readings. All modules had messages instructing users to contact the clinic or to go to the emergency department when critical parameters were out of range. To assist with adherence, an automated phone call was sent to patients based on the required frequency of each condition's algorithm."

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 briefly explain why the item is not applicable/relevant for your study "In addition, the siloed nature of specialty care made it such that even when the technology could support the simultaneous management of HF, DM, and HT, patients were only monitored for the condition being managed at the location of enrollment. As a result, the model of care differed depending on the structure and resources at each clinic. For example, alerts for HF patients were primarily addressed by nurse practitioners who would escalate issues to the treating cardiologist as required. In contrast, telemonitoring alert management for HT and DM was the responsibility of the treating physician."

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). subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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 briefly explain why the item is not applicable/relevant for your study "To assist with adherence, an automated phone call was sent to patients based on the required frequency of each condition's algorithm."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients allocated to the intervention arm were provided with the telemonitoring equipment and user manual before receiving face-to-face training on how to use the equipment." subitem not at all important 1 2 3 4 5 essential 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile 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 "Patients with HF were instructed to monitor daily weight, blood pressure, heart rate, and symptoms. Due to the frequency of readings and higher complexity of the HF Medly algorithm [36], patient feedback was designed to be highly actionable. For example, patients were told to take a dose of their prescribed diuretic and restrict salts and fluids upon a large weight gain. Patients with DM were instructed to record blood glucose readings at least once per week or more as instructed by their HCP and received actionable feedback (e.g., "Eat 15g (1 tbls) of sugar or other fast-acting carbohydrates" in response to low blood glucose readings). Patients with HT were instructed to report their blood pressure once every two weeks unless the readings were out of range, in which case, they would be instructed through the app to increase the frequency of their readings." "Patient adherence was calculated from Medly server log data as a percentage of completed recommended readings over the course of the 6-month trial." "Of the 41 patients who completed the study in the intervention arm, 29 patients used the HF module, 10 patients used the HT module, and 2 patients used the DM module. On average, HF patients completed all 4 readings 78.1% of the days they were enrolled in the 6 month trials. This usage rate increased to 86.2% when looking at the percentage of days HF patients reported at least one reading. Average adherence was 64.2% for the HT patients and 58.3% for DM patients based on a minimum of biweekly and weekly readings for HT and DM, respectively. The combined average adherence across all subjects was 73.1% over the study period. Figure 3 depicts the monthly adherence rates for the 3 disease modules. It shows that although adherence was initially high across all conditions and remained relatively stable for HF patients, it dropped markedly after the second month for HT and DM ti t " subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "All HCPs who used the system and a sample of patients in the intervention group were invited to participate in post-study semi structured interviews which probed their experience in the telemonitoring program. Patients were identified through a convenience sample with efforts made to include patients from the 3 conditions monitored. Interviews took place in a private clinic room or over the telephone and were audio recorded for later transcription.
Qualitative data were analyzed using a conventional content analysis approach [46] by two researchers who first analyzed the transcripts independently and then met to discuss themes until consensus was reached. NVivo version 11 (QSR International) was used to help organize the themes." 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 briefly explain why the item is not applicable/relevant for your study No changes were made to the trial outcomes after the trial commenced.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A total of 146 patients of varying chronic conditions were targeted for enrolment (see sample size justification [33])." Protocol outlines how attrition was taken into account when calculating the sample size.
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 briefly explain why the item is not applicable/relevant for your study No interim analyses and stopping guidelines were applied in this study. 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 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 briefly explain why the item is not applicable/relevant for your study "Patients were then blocked randomized using blocks of 4 into the intervention and standard of care treatments groups in a 1:1 ratio as per the published stratification protocol [33]." 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 briefly explain why the item is not applicable/relevant for your study "Patients were then blocked randomized using blocks of 4 into the intervention and standard of care treatments groups in a 1:1 ratio as per the published stratification protocol [33]." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 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 briefly explain why the item is not applicable/relevant for your study Described in the published protocol referenced in the manuscript.
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 briefly explain why the item is not applicable/relevant for your study Described in the published protocol referenced in the manuscript.

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).

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 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 briefly explain why the item is not applicable/relevant for your study Described in the published protocol referenced in the manuscript.
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 briefly explain why the item is not applicable/relevant for your study Described in the published protocol referenced in the manuscript.
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 briefly explain why the item is not applicable/relevant for your study N/A -Trial compared telemonitoring to standard of care (seeing the clinical team for scheduled follow-ups every 3-6 months, optimization of medical therapy, and selfmanagement education).

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 briefly explain why the item is not applicable/relevant for your study "Questionnaires containing the patient-reported outcome measures were administered at baseline and 6 months [33]. Demographic questions were included in the baseline questionnaire to characterize the study participants. Patient adherence was calculated from Medly server log data as a percentage of completed recommended readings over the course of the 6-month trial.
Post-trial data and change scores were compared between the treatment arms using independent Student t tests and Mann-Whitney tests (for normally and not normally distributed data, respectively). Paired Student t tests and Wilcoxon signed rank tests were performed to compare baseline and post-study data within the control and telemonitoring groups. Analyses were performed using IBM SPSS (Version 27) under the intention-to-treat principle and using a significance P<.05." 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 briefly explain why the item is not applicable/relevant for your study "Therefore, although 45 and 50 patients were allocated to telemonitoring and control arms, only 28 and 26 complete data sets were available for analysis in the telemonitoring and control arms, respectively." 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 briefly explain why the item is not applicable/relevant for your study N/A -No additional analyses were conducted.

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline 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 briefly explain why the item is not applicable/relevant for your study "After confirming eligibility, the coordinator explained the study and obtained informed consent." Consent procedures also described in referenced protocol.

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

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 briefly explain why the item is not applicable/relevant for your study "Patients allocated to the intervention arm were provided with the telemonitoring equipment and user manual before receiving face-to-face training on how to use the equipment." 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 briefly explain why the item is not applicable/relevant for your study " Figure 2. Flow of patient participants through the trial." 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow 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 briefly explain why the item is not applicable/relevant for your study " Figure 2. Flow of patient participants through the trial."

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 figures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure 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 briefly explain why the item is not applicable/relevant for your study " Figure 3 depicts the monthly adherence rates for the 3 disease modules. It shows that although adherence was initially high across all conditions and remained relatively stable for HF patients, it dropped markedly after the second month for HT and DM patients." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 42/57 subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "Patients with HT were recruited from a HT clinic at Mount Sinai Hospital between July-December 2019 and DM patients were recruited from the UHN Endocrinology Clinic between August-December 2019." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant 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 briefly explain why the item is not applicable/relevant for your study "Finally, and most importantly, the COVID-19 pandemic led to a freeze to non-essential research activities and a significant shift toward virtual care which fundamentally altered the control group after the research freeze was lifted.
In addition to ending recruitment, shifting priorities at the onset of COVID-19 also impacted the collection of post-study data as patients followed for HT and DM ended their enrollment during the first wave, which led to a higher rate of incomplete questionnaires." 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 briefly explain why the item is not applicable/relevant for your study "Finally, and most importantly, the COVID-19 pandemic led to a freeze to non-essential research activities and a significant shift toward virtual care which fundamentally altered the control group after the research freeze was lifted. "

15) A
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Study participants were predominantly male (54/96, 76.1%) and had an average age of 59 (SD 12.6) years. These, along with the other demographics presented in Table 1, are representative of the UHN Heart Function Clinic where most of the patient participants were recruited."

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.

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

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: 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 specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "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 briefly explain why the item is not applicable/relevant for your study " subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Analyses were performed using IBM SPSS (Version 27) under the intention-to-treat principle and using a significance P<.05." 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 briefly explain why the item is not applicable/relevant for your study " 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 definitions 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 defined (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 briefly explain why the item is not applicable/relevant for your study "Of the 41 patients who completed the study in the intervention arm, 29 patients used the HF module, 10 patients used the HT module, and 2 patients used the DM module. On average, HF patients completed all 4 readings 78.1% of the days they were enrolled in the 6 month trials. This usage rate increased to 86.2% when looking at the percentage of days HF patients reported at least one reading. Average adherence was 64.2% for the HT patients and 58.3% for DM patients based on a minimum of biweekly and weekly readings for HT and DM, respectively. The combined average adherence across all subjects was 73.1% over the study period. Figure 3 depicts the monthly adherence rates for the 3 disease modules. It shows that although adherence was initially high across all conditions and remained relatively stable for HF patients, it dropped markedly after the second month for HT and DM patients." 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study N/A -No significant effects observed on health status, anxiety and depression, self-efficacy, and most utilization metrics.
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 briefly explain why the item is not applicable/relevant for your study "Self-care maintenance and physical quality of life improved significantly for HF patients in the telemonitoring group (P= .036 and P=.046, respectively). However, none of the betweengroup comparisons were statistically significant, likely due to the general improvement in self-care and quality of life scores of the control group and insufficient sample size to detect changes in condition-specific metrics."

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).

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study N/A -Subgroup analysis of comparing only users was not conducted.

Does your paper address CONSORT subitem 19? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "One death was reported in each treatment arm, however, these were not considered an adverse event of the 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 briefly explain why the item is not applicable/relevant for your study

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 briefly explain why the item is not applicable/relevant for your study "Thirteen of the 41 patients who completed the study in the intervention arm were interviewed, including 8 HF patients, 4 HT patients, and 1 DM patient. The HCPs included 1 cardiologist and 2 cardiac nurse practitioners, 1 hypertension specialist, and 1 endocrinologist. The interview findings, which contribute to explaining the overall null results of the study, are summarized in the following themes: (1) challenges of implementing MCC telemonitoring in a siloed healthcare system; (2) perceptions of the telemonitoring system; (3) perceived benefits differed based on the condition monitored; and (4)  22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In the absence of high-quality evidence on telemonitoring for managing MCCs [47], this study sought to evaluate the impact of a mobile phone based telemonitoring program to manage complex patients in specialty care settings. Through a pragmatic RCT, halted before reaching the intended sample size, we observed no effects of the telemonitoring program on health status, anxiety and depression, self-efficacy, and most utilization metrics. Subgroup analyses of HF patients in the intervention arm found a significant improvement in physical quality of life and self-care maintenance, however, no differences in these groups were observed between treatment arms. The reduction in self-report hospitalization found in the control group could also be seen as a trend in the intervention group but did not reach statistical significance likely due to the small sample size. This reduction for both arms may be partly attributed to the impact of the HF clinic in stabilizing patients." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Consistent with previous studies, we recommend that future research conceive telemonitoring as a program, composed of both the system and its associated model of care. Critically, implementation study designs should be used to assess the feasibility of the program prior to conducting a trial, so that challenges may be identified and addressed [50]."

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 briefly explain why the item is not applicable/relevant for your study "In addition to the recruitment and implementation challenges previously discussed, this study had limitations attributable to the trial's pragmatic nature. First, although the study period was 6 months, the study duration lasted almost 4 years with no overlap in the periods in which HF patients and HT/DM patients were active. This meant that, in addition to inhibiting the exploration of multidisciplinary care coordination, ending recruitment due to COVID-19 contributed to a difference in sample size across conditions. Second, selfreported utilization introduces potential challenges due to recall. Third, unintended selection bias is possible as recruitment relied on busy clinicians identifying eligible patients during clinic hours. We do not have data on patients who might have been eligible but who were never identified by their care team, nor on patients who were approached but did not accept to be introduced to the research coordinator. Finally, the interviews were conducted with a convenience sample of patients, and although all HCPs who were involved in the study in any significant manner were interviewed the number of five HCPs was relatively small "

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 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 53/57 subitem not at all important 1 2 3 4 5 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 briefly explain why the item is not applicable/relevant for your study "Several challenges were encountered during the trial, necessitating deviations from the published protocol, and likely contributed to the null results of the study. Foremost, this trial did not reach its intended sample size of 146. Although the onset of COVID-19 and the rapid shift to virtual care for both arms did bring about the decision to stop recruitment permanently, other important challenges contributed to slow recruitment. Importantly, funding and development challenges contributed to an inability to include the planned chronic obstructive pulmonary disease and chronic kidney disease modules. Similarly, while patients who participated in our study did have MCCs, we were unable to offer monitoring for all the conditions simultaneously because the HF, HT, and DM modules were not initially available at the same time. Therefore, the MCC model of care was never fully tested as there was never a need to explore communication workflows for multidisciplinary care that are inherent to the care of MCCs. Finally, recruitment of patients from the diabetes clinic was challenging due to the emergence of newer continuous glucose monitoring technologies at the time of recruitment "

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 indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This was a pragmatic RCT and thus the intervention was applied in a routine application setting.

OTHER INFORMATION
23) Registration number and name of trial registry 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 briefly explain why the item is not applicable/relevant for your study "Trial Registration: ClinicalTrials.gov NCT03127852, ISRCTN (41238563)" 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 briefly explain why the item is not applicable/relevant for your study "See the published protocol for full criteria [33]."

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The authors wish to thank the trial participants and the HCPs for both their role in facilitating participant recruitment and in the telemonitoring intervention. This study was funded by the Canadian Institutes for Health Research which had no role in this study."

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial 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 briefly explain why the item is not applicable/relevant for your study "ES, HR, JC are considered inventors of the Medly system under the intellectual property policies of the UHN and may benefit from future commercialization of the technology by UHN." yes, major changes yes, minor changes no yes no Other: As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?

Your answer
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