ODYSSEE-vCHAT Pilot Trial for Heart Failure (ODYSSEE-vCHAT)
Heart Failure
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Digital health, Digital counselling, Self-care, Clinical trial, Clinical outcomes, Cognitive-behavioural therapy, Health-related quality of life, Motivational interviewing, eHealth, Social Networking
Eligibility Criteria
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
Sites / Locations
- University Health Network
- Sunnybrook Health Sciences Centre
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
ODYSSEE-vCHAT
eUC
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).
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).