NCT05595655

Randomized Controlled Trial to Test the Efficacy of Motivational Interviewing on Self-care

Completed NA Last updated 26 January 2023

What this trial tests

NA trial testing Motivational Interviewing in Heart Failure in 180 participants. Completed in 17 May 2021.

Timeline

27 May 2017

Primary endpoint
30 May 2020

17 May 2021

Quick facts

Lead sponsor	Azienda Socio Sanitaria Territoriale di Lodi
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	180
Start date	27 May 2017
Primary completion	30 May 2020
Estimated completion	17 May 2021
Sites	1 location across Italy

Drugs / interventions tested

• Motivational Interviewing

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Azienda Socio Sanitaria Territoriale di Lodi

Who can join

Eligibility, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Heart failure (HF) is characterized by an increasing prevalence and burden, representing a public health problem and a major cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF; patients play a key role in the management of their condition, given that several negative health outcomes might be avoided with effective 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.

Methods and analysis: This study protocol designed a prospective, parallel-arm, open-label, three-arm, controlled trial for purposing the aims to test the efficacy of a structured program including scheduled MI interventions in improving self-care behaviors among patients with HF at 3, 6, 9, and 12 months from the enrolment. Secondary aims comprehend the corroboration of the superiority of caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes. 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.

Ethics and dissemination: The study protocol and template consent forms have been reviewed and approved by the Ethical Committee of San Raffaele Hospital (approval #74/INT). Also, the study protocol has been registered at ClinicalTrials.gov (Identifier: …….). Patients and caregivers will have to sign the informed consent forms before the randomisation. Patients and caregivers may leave the study at any time. The withdrawal from the study will not imply any prejudice, as fully documented and explained in the informed consent. Considering the open-access publication, the full protocol will be available freely.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Motivational Interviewing for Enhancing Self-care in Patients With Heart Failure: Protocol for a Randomized Controlled Trial.
   Dellafiore F, Ghizzardi G, Vellone E, Magon A, et al · · 2023 · cited 3× · PMID 36976630 · DOI 10.2196/44629
2. A Single-Center, Randomized Controlled Trial to Test the Efficacy of Nurse-Led Motivational Interviewing for Enhancing Self-Care in Adults with Heart Failure.
   Dellafiore F, Ghizzardi G, Vellone E, Magon A, et al · · 2023 · cited 2× · PMID 36900778 · DOI 10.3390/healthcare11050773