Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate if motivational interviewing, performed remotely through videocalls, is effective to improve self-care in patients with heart failure

Detailed Description
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After signing the informed consent form, patients with heart failure will be assigned to the intervention or control group (1:1). The intervention group will receive a total of seven motivational interviewing sessions over 12 months. The control group will receive the standard care.

Official Title
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Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Motivational interviewing performed remotely through videocalls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of HF according to international guidelines; Class II, III or IV in the New York Heart Association (NYHA) functional; poor self-care, defined as at least two items of the Self-Care Heart Failure Index 7.2 (SCHFI 7.2) with a score of 0, 1 or 2; age ≥ 18 years; having an internet access to allow the videocalls; willingness to sign the informed consent form. - Exclusion Criteria: severe cognitive dysfunction, with a score 0 - 4 on the Six-item screener; acute coronary events event in the prior three months; living in nursing homes a residential settings where self-care cannot be performed; if the patient's informal caregiver is not willing to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing Arm<br>This Arm will receive a remote intervention (via videacalls) based on motivational interviewing to improve self-care. The intervention will be delivered seven time over 12 months. | Behavioral: Motivational interviewing performed remotely through videocalls<br>* Remote motivational interviewing will be performed seven time over 12 months, through videocalls. The first four interventions will be performed within two months and the following three will be performed at five, eight and eleven months from enrollment.<br>|
| No Intervention: Standard care Arm<br>This Arm will receive the standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-care maintenance | Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2 | 3 months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-care maintenance | Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2 | 6, 9 and 12 months from enrollment | 
| Self-care monitoring | Self-care monitoring will be measured with the Self-Care Monitoring Scale of the Self-Care of Heart Failure Index v.7.2 | 3, 6, 9 and 12 months from enrollment | 
| Self-care management | Self-care monitoring will be measured with the Self-Care Management Scale of the Self-Care of Heart Failure Index v.7.2 | 3, 6, 9 and 12 months from enrollment | 
| Self-Care Self-Efficacy levels | Self-Care Self-Efficacy will be measured with the Self-Care Self-Efficacy Scale; this scale gives a score from 0 to 100 with higher score meaning higher self-care self-efficacy | 3, 6, 9 and 12 months from enrollment | 
| Burden of heart failure physical symptoms | The burden of heart failure physical symptom will be measured with the Heart Failure Somatic Perception Scale | 3, 6, 9 and 12 months from enrollment | 
| Disease specific quality of life | The disease-specific quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire | 3, 6, 9 and 12 months from enrollment | 
| Caregiver contribution to heart failure self-care | Will be evaluated with the Caregiver Contribution to Self-Care of Heart Failure Index 2 | 3, 6, 9 and 12 months from enrollment | 
| Caregiver preparedness | Will be evaluated with the Caregiver Preparedness Scale | 3, 6, 9 and 12 months from enrollment | 
| Caregiver burden | Will be evaluated with the Caregiver Burden Inventory | 3, 6, 9 and 12 months from enrollment | 
| Health care service uses | They will be evaluated with a questionnaire developed by the research team. Specifically wi will evaluate patient mortality, hospitalizations and used of emergency services. | 3, 6, 9 and 12 months from enrollment | 
| Patient and caregiver generic quality of life | Generic quality of live in patients and in caregivers will be evaluated with the SF-12 Survey | 3, 6, 9 and 12 months from enrollment | 
| Patient and caregiver anxiety and depression | They will ve evaluated with the Hospital Anxiety and Depression Scale | 3, 6, 9 and 12 months from enrollment | 
| Naturalistic decision making of patients and caregivers | They will be evaluated with the Naturalistic Decision Making Scale (patient and caregiver version) | 3, 6, 9 and 12 months from 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, self-management, behavior change, Video calls