Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 27, 2022
Date Accepted: Jan 10, 2023
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A Tailored Intervention for Self-Care Promotion in patients with Heart Failure: protocol for a randomized controlled trial to test the efficacy of motivational interviewing on self-care
ABSTRACT
Background:
Heart failure (HF) is characterized by an increasing prevalence, representing a public health problem and a significant cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF; patients play a crucial role in managing their condition, given that several adverse health outcomes might be avoided with adequate self-care. Motivational interviewing (MI) has been described by the literature as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers’ availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF.
Objective:
To test the efficacy of a structured program, including scheduled MI interventions in improving self-care maintenance in the three-month follow-up from the enrollment. Secondary aims comprehend the assessment of the effectiveness of the above intervention on secondary outcomes (e.g. self-care monitoring, quality of life, sleep disturbance) and the corroboration of the superiority of caregivers’ participation to the intervention over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes at 3, 6, 9 and 12 months from the enrollment.
Methods:
This study protocol designed a prospective, parallel-arm, open-label, three-arm, controlled trial. Analyses will be performed within the framework of intention-to-treat (ITT). Comparisons between groups will be based on an alpha = 5% and two-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods.
Results:
The data collection was started in May 2016. As of December 2022, we enrolled 60 dyads. We estimate to complete the data collection by February 17, 2023, and to perform data analysis by May 2023. We plan to publish the study results within September 2023.
Conclusions:
Motivational interviewing enhance potential self-care practices in patients with HF and their caregivers. The conduction of this study may support changes in clinical practice to include motivational interviewing to improve self-care for patients with HF. Clinical Trial: ClinicalTrials.gov Identifier: NCT05595655
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