← Back to Search

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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Adherence to heart failure self-care behaviours

Engagement with HF self-care resources

Incidence of HF-related hospitalization

+14 more

Other study objectives

Gender interactions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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