At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of heart failure
- ✓New York Heart Association functional class II-IV
- ✓Inadequate self-care assessed with the Self-Care Heart Failure Index
- ✓Informal caregiver of the enrolled patient willing to participate
- ✕Severe cognitive impairment evaluated with the Six-item screener
- ✕Acute coronary syndrome during the last three months
- ✕Living in a residential setting (e.g., nursing home)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial
In Brief
A clinical study evaluating Motivational interviewing for Heart Failure. Completed, enrolled 510 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.