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

June 30, 2021 updated by: Robert Nolan, University Health Network, Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St.Paul's Hospital- UBC
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

  • Principal Investigator: Robert P Nolan, PhD, University Health Network- University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOP 126118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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