Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 10:38 AM
Study NCT ID:
NCT04966104
Status:
COMPLETED
Last Update Posted:
2024-12-19
First Post:
2021-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ODYSSEE-vCHAT Pilot Trial for Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'An independent statistician logged on to a secure program (managed by the UHN THETA institute) that used randomly permuted blocks to assign subjects to ODYSSEE-vCHAT or the control group. To reduce the chance of patient allocation being predictable, we followed the convention whereby the block sizes and the fraction of each block size were known only by an independent statistician. We tested this algorithm with staff at THETA prior to subject recruitment. Our team of investigators remained blinded to ensure impartiality in decisions about procedures and analyses.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double arm, parallel group, single-blind randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gender interactions', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'Exploratory analyses will be conducted for gender categories represented by participants (male, female, gender fluid or non-binary, and not specified).'}], 'primaryOutcomes': [{'measure': 'Composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization', 'timeFrame': 'Trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'The primary goal of the trial is to evaluate whether use of ODYSSEE-vCHAT versus eUC reduces the risk for a composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization. This data will be collected using the Ontario population-based databases at the Institute for the Clinical Evaluative Sciences (ICES). Data for patients will be linked to ICES databases via Ontario Health Insurance Plan (OHIP) number, first and last name, and date of birth using deterministic/probabilistic linkage (patient unique IKN number).'}], 'secondaryOutcomes': [{'measure': 'Incidence of all-cause mortality', 'timeFrame': 'Trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'This data will be collected using ICES. Data for patients will be linked to ICES databases via OHIP number, first and last name, and date of birth using deterministic/probabilistic linkage (patient unique IKN number).'}, {'measure': 'Incidence of all-cause ED visits', 'timeFrame': 'Trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'This data will be collected using ICES. Data for patients will be linked to ICES databases via OHIP number, first and last name, and date of birth using deterministic/probabilistic linkage (patient unique IKN number).'}, {'measure': 'Incidence of HF-related hospitalization', 'timeFrame': 'Trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'This data will be collected using ICES. Data for patients will be linked to ICES databases via OHIP number, first and last name, and date of birth using deterministic/probabilistic linkage (patient unique IKN number).'}, {'measure': 'Engagement with HF self-care resources', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'Total number of logon minutes, total number of logons, and number of logon days prior to a logon lapse greater than or equal to 2 months'}, {'measure': 'Self-reported health-related quality of life', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': '12-Item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), with clinical interpretation based on a group difference of greater than or equal to 5 points'}, {'measure': 'Adherence to heart failure self-care behaviours', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': '9-Item European Heart Failure Self-care Behaviour scale (EHFScB-9)'}, {'measure': 'Self-reported engagement in activities for living well', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'Evaluation of Goal-Directed Behaviours to Promote Well-Being and Health (EUROIA), developed by the principal investigator'}, {'measure': 'Self-reported overall mental health', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'Mental Component Summary (MCS) of the 36-Item Short-Form survey (SF-36)'}, {'measure': 'Self-reported depression', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': '9-Item Patient Health Questionnaire (PHQ-9)'}, {'measure': 'Self-reported anxiety', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': '7-Item Generalized Anxiety Disorder instrument (GAD-7)'}, {'measure': 'Self-reported loneliness', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': '6-Item Revised UCLA Loneliness Scale (RULS-6)'}, {'measure': 'Self-reported psychological wellbeing', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'Flourishing Scale (FS)'}, {'measure': 'Self-reported involvement in medical care', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': '6-Item Self-Efficacy for Managing Chronic Disease instrument (SEMCD-6)'}, {'measure': 'Self-reported health literacy', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'Developed by the principal investigator'}, {'measure': 'Self-reported physical wellbeing', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ)'}, {'measure': 'Self-reported perceived social support', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'ENRICHD Social Support Instrument (ESSI)'}, {'measure': 'Self-reported alcohol, nicotine, and cannabis use', 'timeFrame': 'Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)', 'description': 'Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital health', 'Digital counselling', 'Self-care', 'Clinical trial', 'Clinical outcomes', 'Cognitive-behavioural therapy', 'Health-related quality of life', 'Motivational interviewing', 'eHealth', 'Social Networking'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '17045884', 'type': 'BACKGROUND', 'citation': 'Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. 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Cardiovasc Ther. 2013 Aug;31(4):230-7. doi: 10.1111/1755-5922.12009.'}, {'pmid': '33464959', 'type': 'BACKGROUND', 'citation': "Nolan RP, Ross HJ, Farkouh ME, Huszti E, Chan S, Toma M, D'Antono B, White M, Thomas S, Barr SI, Perreault S, McDonald M, Zieroth S, Isaac D, Wielgosz A, Mielniczuk LM. Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial. Circ Heart Fail. 2021 Jan;14(1):e007073. doi: 10.1161/CIRCHEARTFAILURE.120.007073. Epub 2021 Jan 19."}, {'type': 'BACKGROUND', 'citation': 'Fezza G, Sansone S, Surikova J, Hustzi E, Ross H and Nolan RP. Patient engagement with an e-Counselling platform is enhanced over 12 months in the CHF-CePPORT trial. Can J Cardiol. 2018;10:148-9.'}, {'pmid': '27026267', 'type': 'BACKGROUND', 'citation': 'Payne AY, Surikova J, Liu S, Ross H, Mechetiuc T, Nolan RP. Usability Testing of an Internet-Based e-Counseling Platform for Adults With Chronic Heart Failure. JMIR Hum Factors. 2015 May 8;2(1):e7. doi: 10.2196/humanfactors.4125.'}, {'pmid': '16209970', 'type': 'BACKGROUND', 'citation': 'Spertus J, Peterson E, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA, Pina I, Tooley J, Weintraub WS, Rumsfeld JS; Cardiovascular Outcomes Research Consortium. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005 Oct;150(4):707-15. doi: 10.1016/j.ahj.2004.12.010.'}, {'pmid': '19147463', 'type': 'BACKGROUND', 'citation': 'Jaarsma T, Arestedt KF, Martensson J, Dracup K, Stromberg A. The European Heart Failure Self-care Behaviour scale revised into a nine-item scale (EHFScB-9): a reliable and valid international instrument. Eur J Heart Fail. 2009 Jan;11(1):99-105. doi: 10.1093/eurjhf/hfn007.'}, {'pmid': '36691152', 'type': 'DERIVED', 'citation': 'Peiris RG, Ross H, Chan CT, Poon S, Auguste BL, Rac VE, Farkouh M, McDonald M, Kaczorowski J, Code J, Duero Posada J, Ong S, Kobulnik J, Tomlinson G, Huszti E, Arcand J, Thomas SG, Akbari A, Maunder R, Grover S, Seto E, Simard A, Pope B, Bains M, McIntyre C, Torbay C, Syed F, Nolan RP. Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial. BMJ Open. 2022 Sep 5;12(9):e059635. doi: 10.1136/bmjopen-2021-059635.'}]}, 'descriptionModule': {'briefSummary': 'INTRODUCTION\n\nPsychological distress and reduced quality of life are prevalent within the heart failure (HF) population. The 1-year rehospitalization (40%) and 5-year mortality (45% for women and 60% for men) rates are high. International task force committees report that medical therapy combined with counselling for HF self-care optimizes clinical outcomes.\n\nHYPOTHESES\n\nAt trial completion (median = 8.5 months, range = 2 to 15 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) is predicted to reduce morbidity and mortality rates. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 4, 8, and 12 and trial completion.\n\nRECRUITMENT\n\nHF patients who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and the community. Accrual of the sample (N = 61) occurred over 13 months.\n\nDESIGN\n\nODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months). It is a single-blind trial, with research personnel blinded (excluding the research coordinator). All patients were provided with free access to their respective digital intervention, ODYSSEE-vCHAT or eUC. Subjects were invited by weekly emails to participate in the resources available to their group. eUC patients were provided with access to educational materials for HF self-care that are available to the public on professional heart health websites. Participation in supplementary programs that provide HF self-care education was not restricted, rather it was monitored by self-report during assessments and will be statistically controlled for during outcome assessments.\n\nANALYSIS\n\nSeparate generalized linear models (GLMs) will evaluate ODYSSEE-vCHAT versus eUC for primary and secondary outcomes. GLMs will be adjusted for baseline assessments and potential covariates. Interactions between treatment arm and gender will be examined for each outcome, using Bonferroni post-hoc comparisons for relevant subgroups. Significance in all tests will be p \\< 0.05, 2-sided.', 'detailedDescription': "BACKGROUND\n\nHF is a progressive clinical syndrome in which the heart is unable to pump oxygenated blood to meet the body's metabolic demands during exercise or at rest. At 55 years, the lifetime risk for HF is 29% for women and 33% for men. HF is a major cause of psychological distress and reduced quality of life. The 1-year rehospitalization rate is 40%. The 5-year mortality rate is 45% and 60% for women and men, respectively.\n\nThe incidence of cardiovascular mortality decreases with incremental adherence to self-care. Improvement in HF self-care also predicts greater quality of life at 12 months. However, in the absence of intervention, only 9-36% of HF patients have moderate to high adherence to these behaviours. Barriers to self-care include poor health literacy and social isolation, which are present in 39% and 25% of HF patients, respectively. These barriers are associated with depressed mood and low motivation, both of which increase the risk for poor clinical outcomes.\n\nHome-based telehealth programs such as the present ODYSSEE-vCHAT digital initiative are changing practice standards for outpatient medical care. A telehealth program of social network support that is integrated with automated digital counselling is central to this proposal. This approach has demonstrated potential to improve overall wellbeing and sustain positive behavioural changes through information sharing, structured presentations, and role modelling.\n\nRATIONALE\n\nTask force statements advocate for digital interventions that are patient-centred, scalable, and can improve clinical outcomes while reducing healthcare costs. Furthermore, the development of home-based telehealth programs such as ODYSSEE-vCHAT is consistent with guidelines for COVID-19 prevention. Furthermore, integrating a social network intervention with an automated (scalable), evidence-based digital program for HF self-care is likely to optimize therapeutic benefits. A digital social network initiative is central to this trial because of its potential to (i) sustain patient engagement with HF self-care resources, (ii) promote self-care learning and positive role modelling through information sharing and structured presentations, and (iii) improve quality of life and health literacy while reducing perceived social isolation.\n\nHYPOTHESES\n\nThe primary hypothesis is that ODYSSEE-vCHAT versus eUC will reduce the risk for a composite index of incident all-cause mortality, all-cause emergency department (ED) visits, and HF-related hospitalization (based on linkage to health administrative a data base) at trial completion (median = 8.5 months, range = 2 to 15 months).\n\nThe secondary hypothesis is that engagement with HF self-care resources \\[defined by (i) sum logon minutes, (ii) sum logons, and (iii) number of logon days prior to a logon lapse ≥ 2 months\\] at months 4, 8, and 12 and trial completion (range = 2 to 15 months) will be independently associated with the following outcomes:\n\n* Health-related quality of life\n* Adherence to HF self-care\n* Engagement in activities for living well\n* Overall mental health\n* Health literacy\n* Active involvement in medical care\n* Perceived social support\n* Depression\n* Anxiety\n* Loneliness\n* Use of alcohol, cigarettes, and cannabis\n\nPOTENTIAL RISKS\n\nParticipants may have experienced discomfort with the following:\n\n* Responding to items in the assessments that are considered personal\n* Using ODYSSEE-vCHAT because they are not familiar with the software\n* Verbally contributing to the discussion segments of the webcasts as their voice would be recorded\n* Submitting an audio or video response to the webcasts because they would no longer be an anonymous participant (audio or video comments may also be used for research and educational purposes in the public domain)\n\nSAFETY PARAMETERS\n\nRefusals to respond to any item(s) posed in the questionnaire packages were accommodated.\n\nVideo tutorials on how to use ODYSSEE-vCHAT were provided. Assistance over the telephone was offered when required.\n\nDuring webcasts, visual input from patients remained disabled to protect their identification. If participants preferred to contribute to the discussion without speaking, they were encouraged to use the chat feature on Zoom instead. Comments written in the chat were not included in the recording of the session.\n\nParticipants' audio or video comments were censored for inappropriate comments pertaining to violence, sexual content, coarse language, etc. In regards to videos that were selected for presentation to other participants in the trial, or to the public, patients were notified so that they have an opportunity to grant or withhold their permission for this use of their video.\n\nSocial network chatrooms are HIPPA compliant and moderated by three levels of content filtering to ensure that posts meet conventional standards of ethical conduct. Level 1 was a search algorithm that is automatically updated with banned word lists. Level 2 was carried by patient volunteers through self-report. Level 3 is performed by research assistants.\n\nFinally, subjects in the intervention arm were offered an opportunity to send the unblinded research coordinator photographs via email which depict heart-healthy lifestyles. Patients were asked not to include any identifying, sensitive, or personal information (e.g., faces, family members, personal health information, etc.) in the photographs, which would be shared with other participants to encourage social interaction. Participants were informed that they could contact the research team at any time to have their photo submissions withdrawn.\n\nSTATISTICAL PLAN\n\nPrimary outcome:\n\nAt trial completion (median = 8.5 months, range = 2 to 15 months), a time-to-event analysis will be conducted using a multivariable Cox Proportional Hazards model to evaluate if ODYSSEE-vCHAT versus eUC reduced the composite endpoint. Potential confounders will be selected using forward (p \\< 0.05) and backward (p \\< 0.10) stepwise selection.\n\nSecondary outcomes:\n\nGLMs will evaluate if ODYSSEE-vCHAT versus eUC evokes greater program adherence at months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months), adjusting for potential baseline confounders. The GLM will be repeated using sum logons as the dependent variable. A multivariable Poisson model will evaluate whether ODYSSEE-vCHAT versus eUC is associated with greater duration of engagement, adjusting for potential confounding variables. Separate GLMs will evaluate if ODYSSEE-vCHAT versus eUC improves self-reported outcomes at months 4, 8, and 12 and trial completion, adjusting for endpoints at baseline and potential baseline covariates. Clinical interpretation for health-related quality of life will be based on a group difference of greater than or equal to 5 points. Bonferroni post-hoc tests will be used to assess interactions for relevant groups. Significance in all tests will be p \\< 0.05, 2-sided.\n\nExploratory outcomes:\n\nSeparate analyses will be conducted for gender. The Cox Proportional Hazards Model or competing risk models will be used for HF-specific endpoints of mortality, hospitalization, and ED visits, separately and collectively.\n\nDEVIATIONS FROM STATISTICAL PLAN\n\nA need to deviate from the statistical plan was not expected as it involves exploratory analyses. Nevertheless, the Statistical Analysis and Methodology Committee was consulted regularly throughout the trial. Any unplanned analyses will be adjusted using the Bonferroni procedure.\n\nSAMPLE SIZE\n\nResearchers recently reported a reduction over 12 months in a composite index score of all-cause mortality and hospitalization for telehealth support (50.6%) versus usual care (59.3%), p = 0.01. This yielded a sample estimate of 142. Using a 14.7% adjustment rate (142 × 1.147) for withdrawal or attrition based on values obtained from CHF-CePPORT (6.5% of patients withdrew and 8.2% were lost to follow-up), the final sample size estimate was 162, with a type 1 error of 5% and a power of 80%. However, the accrued sample size was N = 61.\n\nCOMPLIANCE\n\nAttendance for assessments was facilitated by telephone and email reminders if a participant fails to complete an assessment within 5 to 7 days of receiving the initial invitation.\n\nWITHDRAWAL\n\nAdverse events such as an unforeseen mental health crisis may have affected a patient's ability to participate in this trial. In cases of patient withdrawal, all data up to this point pertaining to the patient will be used for outcome analyses. The Steering Committee were responsible for reviewing how and whether the subject should be replaced in the trial. The referring cardiologist would have been alerted about the withdrawal.\n\nCRITERIA FOR TRIAL TERMINATION\n\nThe ODYSSEE-vCHAT trial would have been terminated prematurely in the event of a recurrent adverse event that was related to our trial procedures or content.\n\nQUALITY CONTROL AND ASSURANCE\n\nThe Data Review or Monitoring Committee ensured that the trial met an appropriate standard for data quality control. The Steering Committee adjudicated primary and secondary outcomes, as well as reviewed and advised the team about the trial's progress, protocol compliance, and any adverse incidents.\n\nCONSENT\n\nCardiologists and their nursing staff in participating outpatient clinics identified patients who met trial criteria and obtained verbal consent to be approached by the research team. Research personnel either approached the potential participant in the clinic or entered electronic patient records to obtain their contact information. Informed consent was obtained in person or virtually.\n\nThis trial was advertised to HF patients on patient education websites, on posters in participating outpatient clinics, and through mass emails. Patients who contacted the research team through advertising were sent our Referral Form via email to be completed and returned via email by their physician. The Referral Form screened potential participants based on the inclusion and exclusion criteria. Potential participants who qualified for the trial were then directed through the consenting process virtually.\n\nDATA STORAGE\n\nAll data is stored on secure servers within the UHN digital environment and will remain there for at least 10 years after trial completion.\n\nData will be available from the corresponding author pending approval of research ethics boards of participating institutions and on reasonable request received from qualified researchers trained in human subject confidentiality protocols.\n\nPRIVACY AND CONFIDENTIALITY\n\nSubjects are issued a tracking number when data involving identifying information is transmitted for analysis. Subject anonymity and confidentiality has been preserved. Only aggregate data will be published.\n\nAll research personnel have signed an employee confidentiality agreement ensuring that confidential information is not disclosed to any other person or entity. All source documents containing personal identifiers are stored in filing cabinets under lock and key. The database is stored electronically on the firewall-protected server, making it inaccessible externally. Access to the room containing the research file server is restricted to designated persons who are employed by the Behavioural Cardiology Research Unit at the UHN.\n\nDiscussion of the trial with persons outside the research team will never reveal personal identifiers of participants. All access to data is denied to persons outside the research team. Data transmission occurs via encrypted storage material over the Internet."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Biological males and females who are at least 18 years old and diagnosed with HF with reduced, mid-range, or preserved ejection fraction corresponding to the New York Heart Association Classes 2 to 4 (NYHA II-IV) for 3 or more months prior to enrollment\n* Reduced (less than or equal to 40%), mid-range (41 to 49%), or preserved (equal to or greater than 50%) left ventricular ejection fraction, with documentation by ventriculography or quantitative echocardiography (these data are readily available as per the standard of care)\n* No worsening of HF for 1 month prior to recruitment, as determined by a referring physician\n* Receiving medical treatment in compliance with the Canadian Cardiovascular Society's guideline-directed therapy for at least 1 month prior to enrollment\n* Oral and written comprehension of English\n* Personal access to an email address, a computer, and the Internet\n* Informed written consent\n\nExclusion criteria:\n\n* Scheduled for advanced surgical therapy (e.g., heart transplantation or implantation of a left ventricular assistive device) within 3 months of enrollment\n* Record of significant comorbidities at enrollment that is expected to prohibit full participation (e.g., dementia, psychosis, or severe depression)\n* HF secondary to uncorrected valvular cardiomyopathy, predominant right-sided HF, or a non-cardiac disease"}, 'identificationModule': {'nctId': 'NCT04966104', 'acronym': 'ODYSSEE-vCHAT', 'briefTitle': 'ODYSSEE-vCHAT Pilot Trial for Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'ODYSSEE-vCHAT Pilot Trial: a Virtual Community Promoting Health Literacy, Self-Care, and Peer Support for Heart Failure', 'orgStudyIdInfo': {'id': '20-5960'}, 'secondaryIdInfos': [{'id': 'PJT173222', 'type': 'OTHER_GRANT', 'domain': 'Canadian Institutes of Health Research (CIHR)'}, {'id': '5117', 'type': 'OTHER', 'domain': 'Sunnybrook Hospital Research Ethics Board'}, {'id': '21-022-E', 'type': 'OTHER', 'domain': 'Mount Sinai Hospital Research Ethics Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ODYSSEE-vCHAT', 'description': "ODYSSEE-vCHAT consisted of:\n\n* Automated digital counselling resources (educational pages, videos, tools, and trackers)\n* Chatrooms available 24/7\n* Weekly 30-minute webcasts led by a healthcare professional or patient representative\n\nEach aspect was informed by a rotating schedule of 7 weekly self-care themes. Webcasts were recorded and streamed to our private YouTube channel, and associated hyperlinks were shared on the program. Subjects had the option of submitting photographs depicting heart-healthy lifestyles and activities (with no identifying, sensitive, or personal information) to the Gallery Wall.\n\nSubjects were invited by email to access the resources available to them. They logged on to the program using password-protected personal accounts. Each participant's total number of logins and login time (with timestamps) were recorded. Assessments occurred online at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months).", 'interventionNames': ['Behavioral: ODYSSEE-vCHAT']}, {'type': 'NO_INTERVENTION', 'label': 'eUC', 'description': 'eUC provided educational HF self-care resources that are available to the public on professional heart health websites (e.g., Heart Failure Society of Canada, American Heart Association, European Society of Cardiology, Health Canada). Patients were provided with unlimited access to these resources. Subjects were invited by weekly emails to partake in these resources. Self-reported assessments are administered at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months).'}], 'interventions': [{'name': 'ODYSSEE-vCHAT', 'type': 'BEHAVIORAL', 'description': 'Automated digital counselling program with social network support', 'armGroupLabels': ['ODYSSEE-vCHAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M2N 7A2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Rob P Nolan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}