Clinical trial NCT01864369: Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT
Official title: Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
e-counseling
quality of life
self-care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2013-05-29
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life: Kansas City Cardiomyopathy Questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Program engagement and usability
timeFrame: 4- and 12- months
measure: Behavioral,functional and clinical outcomes
timeFrame: 4- and 12- months
measure: Behavioral, clinical and funcitonal outcomes
timeFrame: 4 and 12- months
measure: Behavioral, functional and clinical outcomes
timeFrame: 4- and 12- months
measure: Behavioral, functional and clinical outcomes
timeFrame: 4- and 12- months
measure: Behavioral, functional and clinical outcomes
timeFrame: 4- and 12- months
measure: Clinical and functional assesments.
timeFrame: 12-months
measure: Behavioral, functional and clinical outcomes
timeFrame: 4- and 12- months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St.Paul's Hospital- UBC
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: University Health Network- University of Toronto
name: Robert P Nolan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan RP, Ross HJ, Farkouh ME, Huszti E, Chan S, Toma M, D'Antono B, White M, Thomas S, Barr SI, Perreault S, McDonald M, Zieroth S, Isaac D, Wielgosz A, Mielniczuk LM. Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial. Circ Heart Fail. 2021 Jan;14(1):e007073. doi: 10.1161/CIRCHEARTFAILURE.120.007073. Epub 2021 Jan 19.
citation: Nolan RP, Payne AY, Ross H, White M, D'Antono B, Chan S, Barr SI, Gwadry-Sridhar F, Nigam A, Perreault S, Farkouh M, McDonald M, Goodman J, Thomas S, Zieroth S, Isaac D, Oh P, Rajda M, Chen M, Eysenbach G, Liu S, Zbib A. An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2014 Jan 30;3(1):e5. doi: 10.2196/resprot.2957.