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

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Heart Failure

Treatments

Behavioral: eCounseling + Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT01864369
MOP 126118

Details and patient eligibility

About

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.

Enrollment

248 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

248 participants in 2 patient groups

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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