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

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Behavioral: Motivational interviewing performed remotely through videocalls

• Registration Number: NCT05205018
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-24
• Study Start: 2022-10-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-08
• Primary Completion: 2023-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

1. a diagnosis of HF according to international guidelines;
2. Class II, III or IV in the New York Heart Association (NYHA) functional;
3. 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;
4. age ≥ 18 years;
5. having an internet access to allow the videocalls;
6. willingness to sign the informed consent form. -

Exclusion Criteria

1. severe cognitive dysfunction, with a score 0 - 4 on the Six-item screener;
2. acute coronary events event in the prior three months;
3. living in nursing homes a residential settings where self-care cannot be performed;
4. if the patient's informal caregiver is not willing to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational Interviewing Arm	Motivational interviewing performed remotely through videocalls	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.

Primary Outcome Measures

Name	Time	Method
Self-care maintenance	3 months from enrollment	Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital of Alessandria; 🇮🇹 Alessandria, Italy