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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
eCounseling + Usual Care
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Heart Failure, e-counseling, quality of life, self-care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St.Paul's Hospital- UBC
  • University Health Network
  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control: eInfo + Usual Care

Behavioral: eCounseling + Usual Care

Arm Description

Usual Care + eInfo on general guidelines for heart healthy living

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2013
Last Updated
June 30, 2021
Sponsor
University Health Network, Toronto
Collaborators
Heart and Stroke Foundation of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT01864369
Brief Title
Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT
Acronym
CHF-CePPORT
Official Title
Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, e-counseling, quality of life, self-care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control: eInfo + Usual Care
Arm Type
Active Comparator
Arm Description
Usual Care + eInfo on general guidelines for heart healthy living
Arm Title
Behavioral: eCounseling + Usual Care
Arm Type
Experimental
Arm Description
Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools.
Intervention Type
Behavioral
Intervention Name(s)
eCounseling + Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Quality of Life: Kansas City Cardiomyopathy Questionnaire
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Program engagement and usability
Description
Active engagement with digital platform: total time, # logons, % material accessed
Time Frame
4- and 12- months
Title
Behavioral,functional and clinical outcomes
Description
Quality of life: number of subjects with KCCQ ≥5 points
Time Frame
4- and 12- months
Title
Behavioral, clinical and funcitonal outcomes
Description
Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire.
Time Frame
4 and 12- months
Title
Behavioral, functional and clinical outcomes
Description
Physical activity: 4-day step count with Triaxial Accelerometer.
Time Frame
4- and 12- months
Title
Behavioral, functional and clinical outcomes
Description
Self-reported daily activity: The Physical Activity Scale for the Elderly.
Time Frame
4- and 12- months
Title
Behavioral, functional and clinical outcomes
Description
Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression)
Time Frame
4- and 12- months
Title
Clinical and functional assesments.
Description
Functional capacity: 6-minute walk test.
Time Frame
12-months
Title
Behavioral, functional and clinical outcomes
Description
Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety)
Time Frame
4- and 12- months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Nolan, PhD
Organizational Affiliation
University Health Network- University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Paul's Hospital- UBC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33464959
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.
Results Reference
derived
PubMed Identifier
24480783
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.
Results Reference
derived
Links:
URL
http://cardiacehealth.uhnresearch.ca/
Description
General contact

Learn more about this trial

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

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