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

NCT01864369 | Completed DMC

• 1 other identifier: MOP 126118
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Failure

Keywords

Heart Failure; e-counseling; quality of life; self-care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Program engagement and usability

  4- and 12- months

• Behavioral,functional and clinical outcomes

  4- and 12- months

• Behavioral, clinical and funcitonal outcomes

  4 and 12- months

• Behavioral, functional and clinical outcomes

  4- and 12- months

• Behavioral, functional and clinical outcomes

  4- and 12- months

Study Arms (2)

Control: eInfo + Usual Care

ACTIVE COMPARATOR

Usual Care + eInfo on general guidelines for heart healthy living

Behavioral: eCounseling + Usual Care

Behavioral: eCounseling + Usual Care

EXPERIMENTAL

Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools.

Behavioral: eCounseling + Usual Care

Interventions

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.

Behavioral: eCounseling + Usual Care; Control: eInfo + Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (3)

St.Paul's Hospital- UBC

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (3)

• Nolan RP, Syed F, Stogios N, Maunder R, Sockalingam S, Tai ES, Cobain M, Peiris RG, Huszti E. The evaluation of goal-directed activities to promote well-being and health in heart failure: EUROIA scale. J Patient Rep Outcomes. 2024 Apr 29;8(1):47. doi: 10.1186/s41687-024-00723-x.

  PMID: 38683439 DERIVED

• 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.

  PMID: 33464959 DERIVED

• 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.

  PMID: 24480783 DERIVED

Related Links

• General contact

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Robert P Nolan, PhD

  University Health Network- University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist- Director, Behavioral Cardiology Research Unit

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 29, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 6, 2021

Record last verified: 2021-06

Locations

CA (3)