A Family Intervention for Improving Self-Care of Patients With Heart Failure

Completed · Early Phase 1

Conditions studied: Heart Failure, Congestive

In brief

This is a pilot study of a family-based educational program for patients with heart failure, and their family members.

Key facts

Study ID: NCT00645489
Run by: US Department of Veterans Affairs
People needed: 40
Starts: 2008-03-01
Expected to finish: 2009-12-01
Last updated by the study team: 2010-01-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Stage C Heart Failure,[34] which refers to past or current symptoms of heart failure with underlying structural heart disease. Indicated by chronic systolic dysfunction (left ventricle [LV] ejection fraction < 45%), diastolic dysfunction (with echo evidence of diminished compliance of the LV), or both.
The patient's cardiologist has recommended or initiated one of the following to prevent decompensation: continuing diuretic treatment, fluid restrictions, and/or restriction/reduction of dietary sodium intake.
A family member or members available for study participation with whom patient lives for at least 5 days a week. Emphasis will be given to the closest family members available (i.e., spouse).
Subjects are able to give informed consent (see below for exclusion due to well-documented dementia or evidence of cognitive impairment).
Patients will be age 50 or above. Younger patients may have a different family environment than the most common type of patient who is the target of the FPI intervention.

You may not qualify if…

Patient has a well-documented diagnosis of dementia
Moderate or greater cognitive impairment, based on the Blessed Test of Orientation, Memory, and Concentration (BOMC)[26] score of 16.
Patient's family member has BOMC score of 10 (i.e., mild or greater cognitive impairment).
Inability to communicate verbally, major visual impairment, uncorrected hearing loss.
Patient and/or family member reports "frequent use" illicit substance abuse within the past year. Scores on the AUDIT-C 4 indicating alcohol abuse/dependence.[30]
Patient or family member has a current diagnosis of schizophrenia spectrum psychiatric disorder (e.g., schizophrenia, schizoaffective disorder).
Patient indicates active suicidal ideation and evaluated as a clinical risk.
Patient is in the Philadelphia VAMC home-telehealth program or some other incompatible intervention.
Patient has an unstable medical condition that would likely prevent the subject from completing the study.

Where it is running

VA Medical Center, Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.