Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the rate of death and CHF hospitalization. In the absence of intervention, patient adherence to these behaviors is below recommended standards and quality of life among CHF patients becomes progressively compromised. A major challenge is to make self-care counseling available without overtaxing health care resources. This year multicenter clinical trial will establish and evaluate a Canadian e-platform that provides multidisciplinary e-counseling to help patients with CHF to initiate and maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life, self-care behaviors, program engagement, and heart health. This proposal is based upon previous clinical trials in CHF, e-health and preventive lifestyle counseling by our team. The novel contribution of this research is that it will establish an infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key feature of this proposal is that our multidisciplinary team will work with professional heart health organizations to share our findings and e-health resources with the public and other health care professionals in Canada, which will help to galvanize research and clinical work in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve the quality of life of patients with CHF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
248
This intervention will use film vignettes and interactive web pages. The e-counseling messages will promote: (i) validation of the subject's stage of "readiness" for behavior change, (ii) collaborative participation by means of subject-selected menus, (iii) reinforcement of "change talk" to resolve ambivalence, (iv) use of self-help information and e-tools for self-monitoring of targeted self-care behaviors, and (v) development of cognitive-behavioral skills to build and strengthen efficacy. Messages will be proactively sent to Controls according to the following schedule: weekly for months 1 to 4, bi-weekly for months 5 to 8, and monthly for months 9 to 12.
St.Paul's Hospital- UBC
Vancouver, British Columbia, Canada
University Health Network
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Quality of Life: Kansas City Cardiomyopathy Questionnaire
The primary outcome in CHF-CePPORT is quality of life, as measured by the number of subjects who demonstrate a clinically meaningful increase of ≥5 points on the summary index of the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time frame: 12 months
Program engagement and usability
Active engagement with digital platform: total time, # logons, % material accessed
Time frame: 4- and 12- months
Behavioral,functional and clinical outcomes
Quality of life: number of subjects with KCCQ ≥5 points
Time frame: 4- and 12- months
Behavioral, clinical and funcitonal outcomes
Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire.
Time frame: 4 and 12- months
Behavioral, functional and clinical outcomes
Physical activity: 4-day step count with Triaxial Accelerometer.
Time frame: 4- and 12- months
Behavioral, functional and clinical outcomes
Self-reported daily activity: The Physical Activity Scale for the Elderly.
Time frame: 4- and 12- months
Behavioral, functional and clinical outcomes
Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression)
Time frame: 4- and 12- months
Clinical and functional assesments.
Functional capacity: 6-minute walk test.
Time frame: 12-months
Behavioral, functional and clinical outcomes
Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety)
Time frame: 4- and 12- months
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