Abstract
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).
Highlights
Chronic Heart Failure SyndromeChronic heart failure (CHF) is a progressive clinical syndrome in which the heart is unable to pump oxygenated blood sufficiently to meet metabolic demands during exercise or at rest [1]
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
The e-Counseling protocol in CHF-CePPORT builds upon evidence and know-how that we have shown in our previous trials
Summary
Procedures and Features Procedures and features of our methods have been reviewed according to the Consolidated Standards of Reporting Trials (CONSORT) standards for clinical trials in eHealth [32,33]. Our primary hypothesis is that more subjects in the e-Counseling + Usual Care arm will experience significant improvement in the quality of life at the 12-month assessment than in the Control arm This improvement will be defined as a clinically meaningful increase of ≥5 points [38] on the summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [39] from baseline. Our secondary hypotheses are that the e-Counseling + Usual Care arm will be associated with significant improvement in the quality of life, adherence to self-care, and psychological adjustment from baseline to 4- and 12-month assessments. Patients with CHF will be ineligible if they fit with any of the following exclusion criteria: (1) documentation at enrollment of renal failure (serum-creatinine ≥300 micromoles/L, ≥3.0 mg/dL), significant liver disease (alanine transaminase >3-fold upper limit of normal), or poorly controlled diabetes mellitus (fasting blood glucose >10 mmol/L or hemoglobin A1c >8%, or current diagnosis of autonomic neuropathy, ketoacidosis, or hyperosmolar state), (2) current symptomatic hypotension and/or systolic blood pressure ≤85 mmHg, (3) persistent systolic or diastolic hypertension (systolic >170 mmHg or diastolic >100 mmHg despite antihypertensive therapy), (4) CHF secondary to any of the following conditions–primary uncorrected valvular cardiomyopathy, predominant right-sided heart failure, or noncardiac disease (eg, pericardial disease, complex congenital heart disease), (5) cardiovascular comorbidities/procedures that include stroke, acute myocardial infarction, or planned cardiac surgery within 4 weeks before enrollment, (6) severe obstructive, restrictive, or other chronic pulmonary disease, (7) previous heart transplant or is on a wait list for heart transplant at the time of enrollment, (8) diagnosis of major psychiatric disorder (eg, psychosis) or drug/alcohol abuse in past year, and (9) diagnosis of noncardiac disease (eg, cancer) that is likely to shorten life expectancy to
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