CompletedNot Applicable

ODYSSEE-vCHAT Pilot Trial for Heart Failure

Canada61 participantsStarted 2021-10-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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 Exclusion criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT04966104

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-16

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