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

N/AUnknownNCT05205018

University of Rome Tor Vergata432 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

432

Conditions

Heart Failure

Interventions

Motivational interviewing performed remotely through videocallsBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital of Alessandria

Alessandria, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 3 months from enrollment

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Ercole Vellone, PhD

CONTACT

+393387491811 ercole.vellone@uniroma2.it

Data from ClinicalTrials.gov

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