N/A Completed N=510 Randomized Single-blind Supportive Care

MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

Heart Failure

Source: ClinicalTrials.gov NCT02894502 ↗

Enrolled (actual)

510

Serious AEs

—

Results posted

Feb 2021

Primary outcomePrimary: Self-care Maintenance in Patients — 52.36; 54.23; 49.63 score on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-care Maintenance in Patients	52.36; 54.23; 49.63	—
SECONDARY Burden of HF Symptoms in Patients	24; 17.4; 22.5	—
SECONDARY Patient and Caregiver Generic Physical and Mental Quality of Life	—	—
SECONDARY Patient and Caregiver Anxiety and Depression	—	—
SECONDARY Patient HF Specific Quality of Life	—	—
SECONDARY Patient and Caregiver Quality of Nocturnal Sleep	—	—
SECONDARY Patient and Caregiver Mutuality	—	—
SECONDARY Caregiver Preparedness	—	—
SECONDARY Caregiver Perceived Social Support	—	—
SECONDARY Patient Hospitalizations	—	—
SECONDARY Use of Emergency Services	—	—
SECONDARY Death	128; 145; 133; 3; 1; 9	—

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02894502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.