Status:
COMPLETED
A Family Intervention for Improving Self-Care of Patients With Heart Failure
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
50+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a pilot study of a family-based educational program for patients with heart failure, and their family members.
Detailed Description
1. Objectives(s): We plan to conduct a feasibility pilot trial of the Family Partnership Intervention (FPI) compared to patients in the HF Wait-list (WL) condition. We plan to demonstrate feasibility,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00645489
Start Date
March 1 2008
End Date
December 1 2009
Last Update
January 6 2010
Active Locations (1)
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1
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104