Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT

Study Overview
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Brief Summary
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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.

Official Title
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Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: eCounseling + Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients 18 years of age who are diagnosed with heart failure with reduced ejection fraction (systolic HF) corresponding to New York Heart Association Class II-III for 3 months prior to enrolment; documentation of LVEF 40%; subject has access to a personal computer; Exclusion Criteria: Documentation at enrolment of renal failure, significant liver disease or poorly controlled diabetes mellitus; persistent systolic or diastolic hypertension [systolic > 170 mmHg or diastolic > 100 mmHg despite antihypertensive therapy; CHF secondary to cardiovascular co-morbidities/procedures; previous heart transplant or wait listed for heart transplant at time of enrolment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control: eInfo + Usual Care<br>Usual Care + eInfo on general guidelines for heart healthy living | Behavioral: eCounseling + Usual Care<br>* 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.<br>|
| Experimental: Behavioral: eCounseling + Usual Care<br>Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools. | Behavioral: eCounseling + Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program engagement and usability | Active engagement with digital platform: total time, # logons, % material accessed | 4- and 12- months | 
| Behavioral,functional and clinical outcomes | Quality of life: number of subjects with KCCQ ≥5 points | 4- and 12- months | 
| Behavioral, clinical and funcitonal outcomes | Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire. | 4 and 12- months | 
| Behavioral, functional and clinical outcomes | Physical activity: 4-day step count with Triaxial Accelerometer. | 4- and 12- months | 
| Behavioral, functional and clinical outcomes | Self-reported daily activity: The Physical Activity Scale for the Elderly. | 4- and 12- months | 
| Behavioral, functional and clinical outcomes | Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression) | 4- and 12- months | 
| Clinical and functional assesments. | Functional capacity: 6-minute walk test. | 12-months | 
| Behavioral, functional and clinical outcomes | Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety) | 4- and 12- months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, e-counseling, quality of life, self-care