MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

Not Applicable

Completed

Conditions: Heart Failure

Interventions: Behavioral: Motivational interviewing

Registration Number: NCT02894502

Lead Sponsor: University of Rome Tor Vergata

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 510

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational interviewing to patients and caregivers	Motivational interviewing	In this arm the interventions will be delivered both to patients and caregivers
Motivational interviewing only for patients	Motivational interviewing	In this arm the interventions will be delivered only to patients

Primary Outcome Measures

Name	Time	Method
Self-care Maintenance in Patients	3 months from the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Patient HF Specific Quality of Life	3, 6, 9 and 12 months from the intervention	Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire
Patient and Caregiver Quality of Nocturnal Sleep	3, 6, 9 and 12 months from the intervention	We will use the Pittsburgh Sleep Quality Index
Caregiver Preparedness	3, 6, 9 and 12 months from the intervention	Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale
Burden of HF Symptoms in Patients	3, 6, 9 and 12 months from the intervention	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.
Patient and Caregiver Generic Physical and Mental Quality of Life	3, 6, 9 and 12 months from the intervention	Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).
Patient and Caregiver Anxiety and Depression	3, 6, 9 and 12 months from the intervention	Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale
Patient and Caregiver Mutuality	3, 6, 9 and 12 months from the intervention	We will use the Mutuality Scale
Caregiver Perceived Social Support	3, 6, 9 and 12 months from the intervention	We will use the Multidimensional Scale of Perceived Social Support Scale
Death	3, 6, 9 and 12 months from the intervention	Death rates will be evaluated in the three arms of the study by caregiver interview at 3, 6, 9 and 12 months from the intervention.
Patient Hospitalizations	3, 6, 9 and 12 months from the intervention	The number of patient hospitalizations will be measured asking the caregiver how many time the patient was hospitalized from at 3, 6, 9 and 12 months from the intervention.
Use of Emergency Services	3, 6, 9 and 12 months from the intervention	How many times the patient has used the emergency services will be evaluated by asking the caregiver how many time the patient used after 3, 6, 9 and 12 months from the intervention.