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MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF)

U

University of Rome Tor Vergata

Status

Completed

Conditions

Heart Failure

Treatments

Behavioral: Motivational interviewing

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

510 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

510 participants in 3 patient groups

Motivational interviewing only for patients
Experimental group
Description:
In this arm the interventions will be delivered only to patients
Treatment:
Behavioral: Motivational interviewing
Motivational interviewing to patients and caregivers
Experimental group
Description:
In this arm the interventions will be delivered both to patients and caregivers
Treatment:
Behavioral: Motivational interviewing
Control group
No Intervention group
Description:
This Group will receive the usual care

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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