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

MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02894502 ↗

Enrolled (actual)

510

Serious AEs

—

Results posted

Feb 2021

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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Motivational interviewing (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rome Tor Vergata
Primary completion: Oct 2018

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	—

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.

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.