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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: eCounseling + Usual Care

• Registration Number: NCT01864369
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Study Start: 2013-09
• Primary Completion: 2018-01
• Study Completion: 2018-07
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

1. 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;
2. documentation of LVEF 40%;
3. subject has access to a personal computer;

Exclusion Criteria

1. Documentation at enrolment of renal failure, significant liver disease or poorly controlled diabetes mellitus;
2. persistent systolic or diastolic hypertension [systolic > 170 mmHg or diastolic > 100 mmHg despite antihypertensive therapy;
3. CHF secondary to cardiovascular co-morbidities/procedures;
4. previous heart transplant or wait listed for heart transplant at time of enrolment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral: eCounseling + Usual Care	eCounseling + Usual Care	Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools.
Control: eInfo + Usual Care	eCounseling + Usual Care	Usual Care + eInfo on general guidelines for heart healthy living

Primary Outcome Measures

Name	Time	Method
Quality of Life: Kansas City Cardiomyopathy Questionnaire	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Program engagement and usability	4- and 12- months	Active engagement with digital platform: total time, # logons, % material accessed
Behavioral,functional and clinical outcomes	4- and 12- months	Quality of life: number of subjects with KCCQ ≥5 points
Behavioral, clinical and funcitonal outcomes	4 and 12- months	Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire.
Behavioral, functional and clinical outcomes	4- and 12- months	Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety)
Clinical and functional assesments.	12-months	Functional capacity: 6-minute walk test.

Trial Locations

Locations (3)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

St.Paul's Hospital- UBC; 🇨🇦 Vancouver, British Columbia, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada