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ODYSSEE-vCHAT for Heart Failure (ODYSSEE-vCHAT Trial)

N/A

Waitlist Available

Led By Rob P Nolan, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ODYSSEE-vCHAT Trial Summary

This trial is designed to test whether or not a digital program called ODYSSEE-vCHAT can reduce morbidity and mortality rates in heart failure patients, as well as improve their mental and physical health. The trial will last for a median of 14 months and will involve 162 patients.

Who is the study for?

This trial is for adults diagnosed with heart failure (HF) who have had stable HF for at least one month and are following Canadian Cardiovascular Society's treatment guidelines. They must understand English, have email and internet access, and not be scheduled for advanced heart surgeries or burdened by severe comorbidities like dementia.Check my eligibility

What is being tested?

The ODYSSEE-vCHAT pilot trial tests a digital intervention against enhanced usual care (eUC) to see if it reduces morbidity and mortality in HF patients. It's a randomized controlled trial where participants get either the ODYSSEE-vCHAT program or eUC resources, with follow-ups over an average of 8.5 months.See study design

What are the potential side effects?

Since this study involves a digital intervention rather than medication, traditional side effects are not applicable. However, there may be indirect effects such as frustration or stress from technology use which will be monitored.

ODYSSEE-vCHAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Adherence to heart failure self-care behaviours

Engagement with HF self-care resources

Incidence of HF-related hospitalization

+14 more

Other outcome measures

Gender interactions

ODYSSEE-vCHAT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ODYSSEE-vCHATExperimental Treatment1 Intervention

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).

Group II: eUCActive Control1 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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,471 Previous Clinical Trials

484,808 Total Patients Enrolled

26 Trials studying Heart Failure

17,460 Patients Enrolled for Heart Failure

Sunnybrook Health Sciences CentreOTHER

656 Previous Clinical Trials

1,550,515 Total Patients Enrolled

5 Trials studying Heart Failure

46,592 Patients Enrolled for Heart Failure

Mount Sinai Hospital, CanadaOTHER

196 Previous Clinical Trials

67,446 Total Patients Enrolled

5 Trials studying Heart Failure

1,157 Patients Enrolled for Heart Failure

Media Library

ODYSSEE-vCHAT Clinical Trial Eligibility Overview. Trial Name: NCT04966104 — N/A

Heart Failure Research Study Groups: ODYSSEE-vCHAT, eUC

Heart Failure Clinical Trial 2023: ODYSSEE-vCHAT Highlights & Side Effects. Trial Name: NCT04966104 — N/A

ODYSSEE-vCHAT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04966104 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the clinical trial comprising of?

"Affirmative. Clinicaltrials.gov showcases that this clinical trial, which was published on October 25th 2021, is currently recruiting participants. Approximately 162 individuals must be recruited from 3 separate sites to complete the study's objectives."

Answered by AI

Are participants still being enrolled for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical endeavor is currently enrolling patients; it was initially posted on October 25th 2021 and the listing has been updated most recently on September 26th 2022. The research team seeks 162 participants across 3 sites for their study."

Answered by AI

What is the ultimate goal of this experiment?

"This medical trial has an estimated duration of 14 months (with a range of 6-22 months) and aims to evaluate the composite index of incident all-cause mortality, ED visits, and chronic heart failure related hospitalizations. Secondary objectives include measuring incidence of CHF-related hospitalization through ICES databases linked by OHIP numbers, first/last name, DOB using probabilistic linkage; self reported alcohol/nicotine/cannabis use via ASSIST screening test; psychological wellbeing as per Flourishing Scale measurements."

Answered by AI

Has the ODYSSEE-vCHAT system received clearance from the FDA?

"Our team at Power has assigned ODYSSEE-vCHAT a safety score of 2 due to the limited evidence available that supports its security; there is adequate data concerning safety yet no efficacy tests have been carried out."

Answered by AI

Recent research and studies

European Heart JournalJournal

E-health: A Position Statement of the European Society of Cardiology

Cowie, Martin R., Jeroen Bax, Nico Bruining, John G. F. Cleland, Friedrich Koehler, Marek Malik, Fausto Pinto, Enno van der Velde, and Panos Vardas. 2015. “E-health: A Position Statement of the European Society of Cardiology”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehv416.

PLoS MedicineJournal

Combined Impact of Health Behaviours and Mortality in Men and Women: The Epic-norfolk Prospective Population Study

Khaw, Kay-Tee, Nicholas Wareham, Sheila Bingham, Ailsa Welch, Robert Luben, and Nicholas Day. 2008. “Combined Impact of Health Behaviours and Mortality in Men and Women: The Epic-norfolk Prospective Population Study”. Edited by Alan Lopez. Plos Medicine. Public Library of Science (PLoS). doi:10.1371/journal.pmed.0050012.

JamaJournal

Relationship Between Adherence to Evidence-based Pharmacotherapy and Long-term Mortality After Acute Myocardial Infarction

Rasmussen, Jeppe N., Alice Chong, and David A. Alter. 2007. “Relationship Between Adherence to Evidence-based Pharmacotherapy and Long-term Mortality After Acute Myocardial Infarction”. Jama. American Medical Association (AMA). doi:10.1001/jama.297.2.177.

Journal of Cardiovascular NursingJournal