An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol

Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidis...

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Published inJMIR research protocols Vol. 3; no. 1; p. e5
Main Authors Nolan, Robert P, Payne, Ada YM, Ross, Heather, White, Michel, D'Antono, Bianca, Chan, Sammy, Barr, Susan I, Gwadry-Sridhar, Femida, Nigam, Anil, Perreault, Sylvie, Farkouh, Michael, McDonald, Michael, Goodman, Jack, Thomas, Scott, Zieroth, Shelley, Isaac, Debra, Oh, Paul, Rajda, Miroslaw, Chen, Maggie, Eysenbach, Gunther, Liu, Sam, Zbib, Ahmad
Format Journal Article
LanguageEnglish
Published Canada JMIR Publications 01.01.2014
JMIR Publications Inc
Subjects
Activities of daily living
Behavior
Beta blockers
Cardiomyopathy
Clinical trials
Consent
Counseling
Diet
Documentation
Ejection fraction
Enrollments
Exercise
Heart failure
Heart transplants
Hypotheses
Internet access
Mortality
Patients
Physical fitness
Protocol
Quality of life
Questionnaires
Stress
Telemedicine
Canada
Internet-based intervention
chronic heart failure
quality of life
lifestyle intervention
e-counseling
Online AccessGet full text
ISSN1929-0748
1929-0748
DOI10.2196/resprot.2957

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Abstract Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidisciplinary health care teams helps to improve adherence to self-care behaviors and to reduce the rate of death and hospitalization. In the absence of intervention, adherence to self-care is below recommended standards. This trial aims to establish and evaluate a Canadian e-platform that will provide a core, standardized protocol of behavioral counseling and education to facilitate long-term adherence to self-care among patients with CHF. Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) is a multi-site, double blind, randomized controlled trial with a 2 parallel-group (e-Counseling + Usual Care vs e-Info Control + Usual Care) by 3 assessments (baseline, 4-, and 12-month) design. We will identify subjects with New York Heart Association Class II or III systolic heart failure from collaborating CHF clinics and then recruit them (n=278) by phone. Subjects will be randomized in blocks within each site (Toronto, Montreal, and Vancouver). The primary outcome will be improved quality of life, defined as an increased number of subjects with an improvement of ≥5 points on the summary score of the Kansas City Cardiomyopathy Questionnaire. We will also assess the following secondary outcomes: (1) diet habits, depression, anxiety, smoking history, stress level, and readiness for change using self-report questionnaires, (2) physical activity level, current smoking status, and vagal-heart rate modulation by physiological tests, and (3) exercise capacity, prognostic indicators of cardiovascular functioning, and medication adherence through medical chart review. The primary outcome will be analyzed using generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P<.05. This 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling. CHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF. ClinicalTrials.gov NCT01864369; http://clinicaltrials.gov/ct2/show/NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E).
AbstractList Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidisciplinary health care teams helps to improve adherence to self-care behaviors and to reduce the rate of death and hospitalization. In the absence of intervention, adherence to self-care is below recommended standards. This trial aims to establish and evaluate a Canadian e-platform that will provide a core, standardized protocol of behavioral counseling and education to facilitate long-term adherence to self-care among patients with CHF. Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) is a multi-site, double blind, randomized controlled trial with a 2 parallel-group (e-Counseling + Usual Care vs e-Info Control + Usual Care) by 3 assessments (baseline, 4-, and 12-month) design. We will identify subjects with New York Heart Association Class II or III systolic heart failure from collaborating CHF clinics and then recruit them (n=278) by phone. Subjects will be randomized in blocks within each site (Toronto, Montreal, and Vancouver). The primary outcome will be improved quality of life, defined as an increased number of subjects with an improvement of ≥5 points on the summary score of the Kansas City Cardiomyopathy Questionnaire. We will also assess the following secondary outcomes: (1) diet habits, depression, anxiety, smoking history, stress level, and readiness for change using self-report questionnaires, (2) physical activity level, current smoking status, and vagal-heart rate modulation by physiological tests, and (3) exercise capacity, prognostic indicators of cardiovascular functioning, and medication adherence through medical chart review. The primary outcome will be analyzed using generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P<.05. This 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling. CHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF. ClinicalTrials.gov NCT01864369; http://clinicaltrials.gov/ct2/show/NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E).
Background: Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidisciplinary health care teams helps to improve adherence to self-care behaviors and to reduce the rate of death and hospitalization. In the absence of intervention, adherence to self-care is below recommended standards. Objective: This trial aims to establish and evaluate a Canadian e-platform that will provide a core, standardized protocol of behavioral counseling and education to facilitate long-term adherence to self-care among patients with CHF. Methods: Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) is a multi-site, double blind, randomized controlled trial with a 2 parallel-group (e-Counseling + Usual Care vs e-Info Control + Usual Care) by 3 assessments (baseline, 4-, and 12-month) design. We will identify subjects with New York Heart Association Class II or III systolic heart failure from collaborating CHF clinics and then recruit them (n=278) by phone. Subjects will be randomized in blocks within each site (Toronto, Montreal, and Vancouver). The primary outcome will be improved quality of life, defined as an increased number of subjects with an improvement of ≥5 points on the summary score of the Kansas City Cardiomyopathy Questionnaire. We will also assess the following secondary outcomes: (1) diet habits, depression, anxiety, smoking history, stress level, and readiness for change using self-report questionnaires, (2) physical activity level, current smoking status, and vagal-heart rate modulation by physiological tests, and (3) exercise capacity, prognostic indicators of cardiovascular functioning, and medication adherence through medical chart review. The primary outcome will be analyzed using generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P<.05. Results: This 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling. Conclusions: CHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF. Trial Registration: ClinicalTrials.gov NCT01864369; http://clinicaltrials.gov/ct2/show/NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E).
BackgroundChronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidisciplinary health care teams helps to improve adherence to self-care behaviors and to reduce the rate of death and hospitalization. In the absence of intervention, adherence to self-care is below recommended standards. ObjectiveThis trial aims to establish and evaluate a Canadian e-platform that will provide a core, standardized protocol of behavioral counseling and education to facilitate long-term adherence to self-care among patients with CHF. MethodsCanadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) is a multi-site, double blind, randomized controlled trial with a 2 parallel-group (e-Counseling + Usual Care vs e-Info Control + Usual Care) by 3 assessments (baseline, 4-, and 12-month) design. We will identify subjects with New York Heart Association Class II or III systolic heart failure from collaborating CHF clinics and then recruit them (n=278) by phone. Subjects will be randomized in blocks within each site (Toronto, Montreal, and Vancouver). The primary outcome will be improved quality of life, defined as an increased number of subjects with an improvement of ≥5 points on the summary score of the Kansas City Cardiomyopathy Questionnaire. We will also assess the following secondary outcomes: (1) diet habits, depression, anxiety, smoking history, stress level, and readiness for change using self-report questionnaires, (2) physical activity level, current smoking status, and vagal-heart rate modulation by physiological tests, and (3) exercise capacity, prognostic indicators of cardiovascular functioning, and medication adherence through medical chart review. The primary outcome will be analyzed using generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P<.05. ResultsThis 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling. ConclusionsCHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF. Trial RegistrationClinicalTrials.gov NCT01864369; http://clinicaltrials.gov/ct2/show/NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E).
Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidisciplinary health care teams helps to improve adherence to self-care behaviors and to reduce the rate of death and hospitalization. In the absence of intervention, adherence to self-care is below recommended standards.BACKGROUNDChronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the management of CHF is to promote long-term adherence to self-care behaviors without overtaxing available health care resources. Counseling by multidisciplinary health care teams helps to improve adherence to self-care behaviors and to reduce the rate of death and hospitalization. In the absence of intervention, adherence to self-care is below recommended standards.This trial aims to establish and evaluate a Canadian e-platform that will provide a core, standardized protocol of behavioral counseling and education to facilitate long-term adherence to self-care among patients with CHF.OBJECTIVEThis trial aims to establish and evaluate a Canadian e-platform that will provide a core, standardized protocol of behavioral counseling and education to facilitate long-term adherence to self-care among patients with CHF.Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) is a multi-site, double blind, randomized controlled trial with a 2 parallel-group (e-Counseling + Usual Care vs e-Info Control + Usual Care) by 3 assessments (baseline, 4-, and 12-month) design. We will identify subjects with New York Heart Association Class II or III systolic heart failure from collaborating CHF clinics and then recruit them (n=278) by phone. Subjects will be randomized in blocks within each site (Toronto, Montreal, and Vancouver). The primary outcome will be improved quality of life, defined as an increased number of subjects with an improvement of ≥5 points on the summary score of the Kansas City Cardiomyopathy Questionnaire. We will also assess the following secondary outcomes: (1) diet habits, depression, anxiety, smoking history, stress level, and readiness for change using self-report questionnaires, (2) physical activity level, current smoking status, and vagal-heart rate modulation by physiological tests, and (3) exercise capacity, prognostic indicators of cardiovascular functioning, and medication adherence through medical chart review. The primary outcome will be analyzed using generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P<.05.METHODSCanadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure (CHF-CePPORT) is a multi-site, double blind, randomized controlled trial with a 2 parallel-group (e-Counseling + Usual Care vs e-Info Control + Usual Care) by 3 assessments (baseline, 4-, and 12-month) design. We will identify subjects with New York Heart Association Class II or III systolic heart failure from collaborating CHF clinics and then recruit them (n=278) by phone. Subjects will be randomized in blocks within each site (Toronto, Montreal, and Vancouver). The primary outcome will be improved quality of life, defined as an increased number of subjects with an improvement of ≥5 points on the summary score of the Kansas City Cardiomyopathy Questionnaire. We will also assess the following secondary outcomes: (1) diet habits, depression, anxiety, smoking history, stress level, and readiness for change using self-report questionnaires, (2) physical activity level, current smoking status, and vagal-heart rate modulation by physiological tests, and (3) exercise capacity, prognostic indicators of cardiovascular functioning, and medication adherence through medical chart review. The primary outcome will be analyzed using generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P<.05.This 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling.RESULTSThis 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling.CHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF.CONCLUSIONSCHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF.ClinicalTrials.gov NCT01864369; http://clinicaltrials.gov/ct2/show/NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E).TRIAL REGISTRATIONClinicalTrials.gov NCT01864369; http://clinicaltrials.gov/ct2/show/NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E).
Author Goodman, Jack
Chan, Sammy
Zieroth, Shelley
Eysenbach, Gunther
Farkouh, Michael
D'Antono, Bianca
Barr, Susan I
Zbib, Ahmad
McDonald, Michael
Payne, Ada YM
Perreault, Sylvie
Isaac, Debra
Oh, Paul
White, Michel
Liu, Sam
Nigam, Anil
Rajda, Miroslaw
Ross, Heather
Thomas, Scott
Chen, Maggie
Gwadry-Sridhar, Femida
Nolan, Robert P
AuthorAffiliation 6 Faculty of Medicine University of British Columbia Vancouver, BC Canada
13 Faculty of Medicine University of Manitoba Winnipeg, MB Canada
12 Faculty of Kinesiology and Physical Education University of Toronto Toronto, ON Canada
17 Dalla Lana School of Public Health University of Toronto Toronto, ON Canada
10 Faculté de Pharmacie Université de Montréal Montréal, QC Canada
4 Centre de Recherche Institut de Cardiologie de Montréal Montréal, QC Canada
5 Département de Psychologie Université de Montréal Montréal, QC Canada
9 Department of Medical Health Informatics Lawson Health Research Institute London, ON Canada
15 Department of Cardiac Rehabilitation Toronto Rehabilitation Institute Toronto, ON Canada
18 Centre for Global eHealth Innovation University Health Network Toronto, ON Canada
1 Behavioral Cardiology Research Unit University Health Network Toronto, ON Canada
14 Cardiac Transplant Clinic Libin Cardiovascular Institute of Alberta Calgary, AB Canada
19 Consumer eHealth Heart and Stroke Found
AuthorAffiliation_xml – name: 12 Faculty of Kinesiology and Physical Education University of Toronto Toronto, ON Canada
– name: 3 Division of Cardiology Peter Munk Cardiac Center University Health Network Toronto, ON Canada
– name: 10 Faculté de Pharmacie Université de Montréal Montréal, QC Canada
– name: 13 Faculty of Medicine University of Manitoba Winnipeg, MB Canada
– name: 18 Centre for Global eHealth Innovation University Health Network Toronto, ON Canada
– name: 2 Faculty of Medicine University of Toronto Toronto, ON Canada
– name: 19 Consumer eHealth Heart and Stroke Foundation of Canada Toronto, ON Canada
– name: 6 Faculty of Medicine University of British Columbia Vancouver, BC Canada
– name: 9 Department of Medical Health Informatics Lawson Health Research Institute London, ON Canada
– name: 15 Department of Cardiac Rehabilitation Toronto Rehabilitation Institute Toronto, ON Canada
– name: 4 Centre de Recherche Institut de Cardiologie de Montréal Montréal, QC Canada
– name: 8 Department of Food, Nutrition, and Health University of British Columbia Vancouver, BC Canada
– name: 7 Department of Cardiology St. Paul's Hospital Vancouver, BC Canada
– name: 17 Dalla Lana School of Public Health University of Toronto Toronto, ON Canada
– name: 14 Cardiac Transplant Clinic Libin Cardiovascular Institute of Alberta Calgary, AB Canada
– name: 16 Division of Cardiology Queen Elizabeth II Health Sciences Center Halifax, NS Canada
– name: 1 Behavioral Cardiology Research Unit University Health Network Toronto, ON Canada
– name: 5 Département de Psychologie Université de Montréal Montréal, QC Canada
– name: 11 Division of Cardiology Mount Sinai Hospital Toronto, ON Canada
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/24480783$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Copyright 2014. This work is licensed under http://creativecommons.org/licenses/by/2.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
Robert P Nolan, Ada YM Payne, Heather Ross, Michel White, Bianca D'Antono, Sammy Chan, Susan I Barr, Femida Gwadry-Sridhar, Anil Nigam, Sylvie Perreault, Michael Farkouh, Michael McDonald, Jack Goodman, Scott Thomas, Shelley Zieroth, Debra Isaac, Paul Oh, Miroslaw Rajda, Maggie Chen, Gunther Eysenbach, Sam Liu, Ahmad Zbib. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.01.2014. 2014
Copyright_xml – notice: 2014. This work is licensed under http://creativecommons.org/licenses/by/2.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
– notice: Robert P Nolan, Ada YM Payne, Heather Ross, Michel White, Bianca D'Antono, Sammy Chan, Susan I Barr, Femida Gwadry-Sridhar, Anil Nigam, Sylvie Perreault, Michael Farkouh, Michael McDonald, Jack Goodman, Scott Thomas, Shelley Zieroth, Debra Isaac, Paul Oh, Miroslaw Rajda, Maggie Chen, Gunther Eysenbach, Sam Liu, Ahmad Zbib. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.01.2014. 2014
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Issue 1
Keywords Internet-based intervention
chronic heart failure
quality of life
lifestyle intervention
e-counseling
Language English
License This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
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Snippet Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for the...
Background: Chronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for...
BackgroundChronic heart failure (CHF) is a public health priority. Its age-standardized prevalence has increased over the past decade. A major challenge for...
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StartPage e5
SubjectTerms Activities of daily living
Behavior
Beta blockers
Cardiomyopathy
Clinical trials
Consent
Counseling
Diet
Documentation
Ejection fraction
Enrollments
Exercise
Heart failure
Heart transplants
Hypotheses
Internet access
Mortality
Patients
Physical fitness
Protocol
Quality of life
Questionnaires
Stress
Telemedicine
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Title An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol
URI https://www.ncbi.nlm.nih.gov/pubmed/24480783
https://www.proquest.com/docview/2509257519
https://www.proquest.com/docview/1493797258
https://pubmed.ncbi.nlm.nih.gov/PMC3936276
https://doaj.org/article/43bab684e74949af8c22af6559b79744
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