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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-07-31

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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control: eInfo + Usual Care

Usual Care + eInfo on general guidelines for heart healthy living

Group Type ACTIVE_COMPARATOR

eCounseling + Usual Care

Intervention Type BEHAVIORAL

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.

Behavioral: eCounseling + Usual Care

Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools.

Group Type EXPERIMENTAL

eCounseling + Usual Care

Intervention Type BEHAVIORAL

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.

Interventions

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eCounseling + Usual Care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No