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

NCT05595655 | Completed DMC

• 1 other identifier: Asstlodi-Oct22
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

heart failure; motivational interviewing; self-care

Outcome Measures

Primary Outcomes (1)

• Changes will be assessed in the Level of self-care maintenance - Self-Care of Heart Failure Index 6.2

  self-care behavior consisting in keeping the disease stable

  3, 6, 9, and 12 months from the enrollment

Secondary Outcomes (13)

• Changes will be assessed in the Level of caregivers' involvement - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI)

  3, 6, 9, and 12 months from the enrollment

• Changes will be assessed in the Level of patient's ability to feel the symptoms of HF - Heart Failure Somatic Perception Scale (HFSPS)

  3, 6, 9, and 12 months from the enrollment

• Changes will be assessed in the Level of cognitive impairment- Six Item Screener

  3, 6, 9, and 12 months from the enrollment

• Changes will be assessed in the Level of physical function, symptoms, social function, self-efficacy, and quality of life (QoL) - Kansas City Cardiomyopathy Questionnaire (KCCQ)

  3, 6, 9, and 12 months from the enrollment

• Changes will be assessed in the Level of feeling of intimacy and positive relationship between patient and caregiver -Mutuality Scale (MS)

  3, 6, 9, and 12 months from the enrollment

Study Arms (3)

control group

NO INTERVENTION

The dyads will receive traditional educational treatment only and will complete the questionnaires after 3, 6, 9 and 12 months follow-up post-intervention. Enrolled dyads will be monitored by the research team responsible for recruitment and follow-up.

First interventional arm

OTHER

MI intervention will be administered to patients only and caregivers will receive standard education. The intervention will last approximately 30 minutes. Thereafter, the nurse who performed the MI will contact the patients over the phone 3 times during the first 2 months after MI, to strengthen the intervention. Then, the intervention will be employed again after 3, 6, 9 and 12 months from enrolment. After each MI session, both patients and caregivers will be asked to complete the questionnaires of follow-up post-intervention

Behavioral: Motivational Interviewing

Second interventional arm

EXPERIMENTAL

MI intervention will be administered both to patients and caregivers. The intervention will be administered to the dyad in one session and patients and their caregivers will receive the reinforcing educational treatment calibrated on the specific lacking areas of patients' self-care behaviours. After each MI session, both patients and caregivers will be asked to complete the questionnaires of follow-up post-intervention.

Behavioral: Motivational Interviewing

Interventions

Motivational Interviewing BEHAVIORAL

Motivational Interviewing (MI) is a directive client-centred counselling approach for eliciting behavioral change by helping people to explore and resolve ambivalence. MI considers several critical factors to improving self-care in patients with HF and is based on brief interventions, which are feasible in several healthcare settings.

First interventional arm; Second interventional arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• diagnosis of HF with New York Heart Association (NYHA) Class II-IV;
• no acute coronary events within three months;
• consent to participate in the study;
• score ≤ 2 to at least two items of the Self-Care of Heart Failure Index 6.2 - SCHFI 6.2 at baseline;
• score on Six Item Screener \> 4;
• living at home;
• understanding of spoken and written Italian.

You may not qualify if:

• severe cognitive impairment (score 0-4 on the Six-item Screener);
• acute coronary events that occurred within three months;
• living in nursing homes or residential settings;
• caregivers unwilling to participate in the study.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Lodi: lead

Study Sites (1)

Cardiology

Lodi, Milan, 26903, Italy

Location

Related Publications (1)

• Dellafiore F, Ghizzardi G, Vellone E, Magon A, Conte G, Baroni I, De Angeli G, Vangone I, Russo S, Arrigoni C, Caruso R. Motivational Interviewing for Enhancing Self-care in Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 28;12:e44629. doi: 10.2196/44629.

  PMID: 36976630 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Federica Dellafiore

  Università degli Studi di Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 27, 2022
• Study Start: May 27, 2017
• Primary Completion: May 30, 2020
• Study Completion: May 17, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

IT (1)