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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>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. | |
| Other: First interventional arm<br>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<br>* 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.<br>|
| Experimental: Second interventional arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes will be assessed in the Level of caregivers' involvement - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) | superiority of the caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors | 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) | patient's ability perceive the symptoms of HF | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Level of cognitive impairment- Six Item Screener | patients' cognitive impairment | 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) | HF-specific QoL | 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) | feeling of intimacy and positive relationship between patient and caregiver | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Level of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health - SF-12 | generic health-related QoL | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Level of presence of significant sleep disturbance experienced in the month before the assessment - Pittsburgh Sleep Quality Index (PSQI) | sleep quality | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Level of depression and anxiety - Hospital Anxiety and Depression Scale (HADS) | depression and anxiety | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Level of cognitive impairment - Montreal Cognitive Assessment (MoCA) | mild cognitive impairment | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Number of comorbidities - Charlson Comorbidity Index (CCI) | comorbidities | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Level of caregiver contribution to self-care - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) | caregiver contribution to self-care in patients with HF | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Level of caregiver Preparedness - Caregiver Preparedness Scale (CPS) | Caregiver Preparedness to care | 3, 6, 9, and 12 months from the enrollment | 
| Changes will be assessed in the Level of social support - Multidimensional Scale of Perceived Social Support (MSPSS) | level of social support perceived by HF patients in managing the disease | 3, 6, 9, and 12 months from the enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, motivational interviewing, self-care