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MOTIVATional intErviewing to improve self-care in Heart Failure patients (MOTIVATE-HF): Study protocol of a three-arm multicenter randomized controlled trial
Vellone, Ercole Paturzo, Marco D'Agostino, Fabio Petruzzo, Antonio Masci, Stefano Ausili, Davide Rebora, Paola Alvaro, Rosaria Riegel, Barbara
Vellone, Ercole
Paturzo, Marco
D'Agostino, Fabio
Petruzzo, Antonio
Masci, Stefano
Ausili, Davide
Rebora, Paola
Alvaro, Rosaria
Riegel, Barbara
Abstract
Aims: Heart Failure (HF) self-care improves patient outcomes but trials designed to improve HF self-care have shown inconsistent results. Interventions may be more effective in improving self-care if they mobilize support from providers, promote self-efficacy, increase understanding of HF, increase the family involvement, and are individualized. All of these elements are emphasized in motivational interviewing (MI); few trials have been conducted using MI in HF patients and rarely have caregivers been involved in MI interventions. The aim of this study will be to evaluate if MI improves self-care maintenance in HF patients, and to determine if MI improves the following secondary outcomes: a) in HF patients: self-care management, self-care confidence, symptom perception, quality of life, anxiety/depression, cognition, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; b) in caregivers: caregiver contribution to self-care, quality of life, anxiety/depression, sleep, mutuality with patient, preparedness, and social support. Methods: A three-arm randomized controlled trial will be conducted in a sample of 240 HF patients and caregivers. Patients and caregivers will be randomized to the following arms: 1) MI intervention to patients only; 2) MI intervention to patients and caregivers; 3) standard of care to patients and caregivers. The primary outcome will be measured in patients 3 months after enrollment. Primary and secondary outcomes also will be evaluated 6, 9 and 12 months after enrollment. Conclusion: This study will contribute to understand if MI provided to patients and caregivers can improve self-care. Because HF is rising in prevalence, findings can be useful to reduce the burden of the disease.
Keywords
heart failure, self-care, motivational interviewing, caregivers
Date
2017
Type
Journal article
Journal
Contemporary Clinical Trials
Book
Volume
55
Issue
Page Range
34-38
Article Number
ACU Department
Mary MacKillop Institute for Health Research
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
License
File Access
Controlled