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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Ontario | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: eInfo + Usual Care | Active Comparator | Usual Care + eInfo on general guidelines for heart healthy living |
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| Behavioral: eCounseling + Usual Care | Experimental | Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Program engagement and usability | Active engagement with digital platform: total time, # logons, % material accessed | 4- and 12- months |
| Behavioral,functional and clinical outcomes | Quality of life: number of subjects with KCCQ ≥5 points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Nolan, PhD | University Health Network- University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Paul's Hospital- UBC | Vancouver | British Columbia | V6Z 1Y6 | Canada | ||
| University Health Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38683439 | Derived | 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. | |
| 33464959 | 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. |
| Label | URL |
|---|---|
| General contact | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 4- and 12- months |
| Behavioral, clinical and funcitonal outcomes | Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire. | 4 and 12- months |
| Behavioral, functional and clinical outcomes | Physical activity: 4-day step count with Triaxial Accelerometer. | 4- and 12- months |
| Behavioral, functional and clinical outcomes | Self-reported daily activity: The Physical Activity Scale for the Elderly. | 4- and 12- months |
| Behavioral, functional and clinical outcomes | Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression) | 4- and 12- months |
| Clinical and functional assesments. | Functional capacity: 6-minute walk test. | 12-months |
| Behavioral, functional and clinical outcomes | Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety) | 4- and 12- months |
| Toronto |
| Ontario |
| M5G 2N2 |
| Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| 24480783 | 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. |