MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

University of Rome Tor Vergata510 enrolled

Overview

The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

510

Conditions

Heart Failure

Interventions

Motivational interviewingBEHAVIORAL

The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: Diagnosis of HF (for patient), New York Heart Association (NYHA) functional class II- IV (for patient), Inadequate self-care assessed with the Self-Care Heart Failure Index (for patient), Being the informal caregiver of the patients (for caregiver). Exclusion criteria: Severe cognitive impairment evaluated with the Six-item screener (for patient), Acute coronary syndrome during the last three months (for patient), Living in a residential settings (e.g., nursing home) (for patient), Patients not willing to participate in the study (for caregiver).

Locations (1)

University of Rome Tor Vergata

Rome, Italy

Outcomes

Primary Outcomes

Self-care Maintenance in Patients

Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Since this instrument has three separate scales, we considered as a primary outcome the score of the Self-care Maintenance scale. The Self-Care Maintenance scale has a score between 0 and 100 with higher score meaning better self-care. Self-Care Maintenance is considered adequate when the score is at least 70.

Time frame: 3 months from the intervention

Secondary Outcomes

Burden of HF Symptoms in Patients

Burden of HF symptoms will be measured with the Heart Failure Somatic Perception Scale (HFSPS). The HFSPS has a range score between 0 and 90; the higher the score, the higher the burden of symptoms caused by heart failure.

Time frame: 3, 6, 9 and 12 months from the intervention

Patient and Caregiver Generic Physical and Mental Quality of Life

Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).

Time frame: 3, 6, 9 and 12 months from the intervention

Patient and Caregiver Anxiety and Depression

Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale

Time frame: 3, 6, 9 and 12 months from the intervention

Patient HF Specific Quality of Life

Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire

Time frame: 3, 6, 9 and 12 months from the intervention

Patient and Caregiver Quality of Nocturnal Sleep

We will use the Pittsburgh Sleep Quality Index

Data from ClinicalTrials.gov

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