ODYSSEE-vCHAT Pilot Trial for Heart Failure

NCT04966104 | Completed DMC

• 4 other identifiers: 20-5960PJT173222511721-022-E
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

INTRODUCTION Psychological 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. HYPOTHESES At 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. RECRUITMENT HF 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. DESIGN ODYSSEE-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. ANALYSIS Separate 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.

Conditions

Heart Failure

Keywords

Digital health; Digital counselling; Self-care; Clinical trial; Clinical outcomes; Cognitive-behavioural therapy; Health-related quality of life; Motivational interviewing; eHealth; Social Networking

Outcome Measures

Primary Outcomes (1)

• Composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization

  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).

  Trial completion (median = 8.5 months, range = 2 to 15 months)

Secondary Outcomes (17)

• Incidence of all-cause mortality

  Trial completion (median = 8.5 months, range = 2 to 15 months)

• Incidence of all-cause ED visits

  Trial completion (median = 8.5 months, range = 2 to 15 months)

• Incidence of HF-related hospitalization

  Trial completion (median = 8.5 months, range = 2 to 15 months)

• Engagement with HF self-care resources

  Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)

• Self-reported health-related quality of life

  Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)

Other Outcomes (1)

• Gender interactions

  Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months)

Study Arms (2)

ODYSSEE-vCHAT

EXPERIMENTAL

ODYSSEE-vCHAT consisted of: * Automated digital counselling resources (educational pages, videos, tools, and trackers) * Chatrooms available 24/7 * Weekly 30-minute webcasts led by a healthcare professional or patient representative Each 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. Subjects 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).

Behavioral: ODYSSEE-vCHAT

eUC

NO INTERVENTION

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

ODYSSEE-vCHAT BEHAVIORAL

Automated digital counselling program with social network support

ODYSSEE-vCHAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• No worsening of HF for 1 month prior to recruitment, as determined by a referring physician
• Receiving medical treatment in compliance with the Canadian Cardiovascular Society's guideline-directed therapy for at least 1 month prior to enrollment
• Oral and written comprehension of English
• Personal access to an email address, a computer, and the Internet
• Informed written consent

You may not qualify if:

• Scheduled for advanced surgical therapy (e.g., heart transplantation or implantation of a left ventricular assistive device) within 3 months of enrollment
• Record of significant comorbidities at enrollment that is expected to prohibit full participation (e.g., dementia, psychosis, or severe depression)
• HF secondary to uncorrected valvular cardiomyopathy, predominant right-sided HF, or a non-cardiac disease

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• Mount Sinai Hospital, Canada: collaborator

Study Sites (3)

University Health Network

Toronto, Ontario, M2N 7A2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

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  PMID: 36691152 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rob P Nolan, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double arm, parallel group, single-blind randomized trial

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 19, 2021
• Study Start: October 25, 2021
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)