UnknownNot Applicable

ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients

Canada215 participantsStarted 2021-09-14

Plain-language summary

INTRODUCTION Psychological distress and reduced quality of life are prevalent in patients with chronic heart failure (CHF) and advanced chronic kidney disease (CKD). In addition, persons with CHF or CKD live with increased risk of primary or secondary complications associated with COVID-19, including mortality. International task force committees report that medical therapy combined with counselling for CHF and CKD self-care optimizes clinical outcomes. Digital health initiatives present an effective solution in light of the recent issue of declining patient attendance in essential outpatient appointments due to the increased risk of COVID-19 exposure. HYPOTHESES At study completion (up to 16 months), it is hypothesized that there will be a significant increase from baseline in the proportion of participants with clinically improved or sustained positive mental health. Additionally, greater engagement with the ODYSSEE-vCHAT program is expected to be linked with improved self-reported health- and wellbeing-related outcomes at months 4 and 8 and study completion (up to 16 months). RECRUITMENT Patients with CHF or CKD who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, The Ottawa Hospital, and the community. Accrual of the sample (N = 215) occurred over a 14-month period. DESIGN This is a single group, open label, pre-post study with assessments at baseline, months 4 and 8, and study completion (up to 16 months). ODYSSEE-vCHAT contacted subjects each week inviting them to participate or partake in digital counselling resources, chatrooms, and presentations with group discussions. Participation in supplemental mental health programs was monitored by self-report. ANALYSES A binomial logistic regression will evaluate if there is a greater proportion of participants with positive mental health at study completion. This analysis will assess if the proportion of participants with positive mental health at study completion (up to 16 months) is independently associated with ODYSSEE-vCHAT engagement (login minutes). General linear models will test secondary outcomes, adjusting for baseline assessments and potential covariates. Significance in all tests will be p \< 0.05, 2-sided. Any unplanned analyses will be adjusted for using the Bonferroni procedure.

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 18 years * Diagnosed with CHF, including reduced (≤ 40%), mid-range (≥ 41 and ≤ 49%), or preserved (≥ 50%) ejection fraction based on New York Heart Association Classes 2 to 4 (NYHA II-IV) for 3 or more months prior to enrollment, OR diagnosed with advanced CKD (\> 10% risk of requiring dialysis within 2 years using the 4-variable, 2-year Kidney Failure Risk equation) or end-stage renal disease and on dialysis * 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., transplantation) 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) * Life expectancy \< 1 year

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

Self-reported overall mental health

Timeframe: Baseline and study completion (up to 16 months)

Trial details

NCT IDNCT05560737

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-16

View on ClinicalTrials.gov More Chronic Heart Failure trials