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Completed

NCT Number: NCT01864369

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eCounseling + Usual Care

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.

Primary outcomes

  1. Quality of Life: Kansas City Cardiomyopathy Questionnaire

    Time frame: 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 outcomes

  1. Program engagement and usability

    Time frame: 4- and 12- months

    Active engagement with digital platform: total time, # logons, % material accessed

  2. Behavioral,functional and clinical outcomes

    Time frame: 4- and 12- months

    Quality of life: number of subjects with KCCQ ≥5 points

  3. Behavioral, clinical and funcitonal outcomes

    Time frame: 4 and 12- months

    Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire.

  4. Behavioral, functional and clinical outcomes

    Time frame: 4- and 12- months

    Physical activity: 4-day step count with Triaxial Accelerometer.

  5. Behavioral, functional and clinical outcomes

    Time frame: 4- and 12- months

    Self-reported daily activity: The Physical Activity Scale for the Elderly.

  6. Behavioral, functional and clinical outcomes

    Time frame: 4- and 12- months

    Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression)

  7. Clinical and functional assesments.

    Time frame: 12-months

    Functional capacity: 6-minute walk test.

  8. Behavioral, functional and clinical outcomes

    Time frame: 4- and 12- months

    Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Heart and Stroke Foundation of Ontario

Registry information

Acronym: CHF-CePPORT

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 29, 2013
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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