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

Heart Failure Clinical Trial

— CHF-CePPORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864369
• Other study ID #: MOP 126118
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: July 2018

Study information

• Verified date: June 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	University Health Network	Toronto	Ontario
Canada	St.Paul's Hospital- UBC	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life: Kansas City Cardiomyopathy Questionnaire	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	Program engagement and usability	Active engagement with digital platform: total time, # logons, % material accessed	4- and 12- months
Secondary	Behavioral,functional and clinical outcomes	Quality of life: number of subjects with KCCQ =5 points	4- and 12- months
Secondary	Behavioral, clinical and funcitonal outcomes	Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire.	4 and 12- months
Secondary	Behavioral, functional and clinical outcomes	Physical activity: 4-day step count with Triaxial Accelerometer.	4- and 12- months
Secondary	Behavioral, functional and clinical outcomes	Self-reported daily activity: The Physical Activity Scale for the Elderly.	4- and 12- months
Secondary	Behavioral, functional and clinical outcomes	Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression)	4- and 12- months
Secondary	Clinical and functional assesments.	Functional capacity: 6-minute walk test.	12-months
Secondary	Behavioral, functional and clinical outcomes	Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety)	4- and 12- months

External Links

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