A Family Intervention for Improving Self-Care of Patients With Heart Failure
A Family Intervention for Improving Self-Care of Patients With Heart Failure
This is a pilot study of a family-based educational program for patients with heart failure,
 and their family members.
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, estimate variances of major outcome variables, and to obtain
 preliminary estimates of effect sizes in preparation for subsequent grant applications.
 We will be able to develop a cost-effectiveness model for the relative benefit of FPI
 vs. no family-based for use in longer-term studies.

 2. Research Design: This is a short-term, randomized clinical trial which will involve
 assessments for participants in the FPI condition at a pre-intervention Baseline point,
 immediately post-intervention, and 6 months post-intervention. Participants in the WL
 condition will be assessed at Baseline, undergo an approximately 8 week waiting period,
 and then the FPI. A longer follow-up is not planned based on the purpose of this study
 as a feasibility trial.

 3. Methodology: We plan to randomize 40 Veterans and their family members to either the FPI
 condition or WL condition, in equal proportions. We will recruit patients with at least
 Stage C Heart Failure (NYHA class I - IV) from the Cardiology clinic of the Philadelphia
 VAMC. FPI will involve 4-6 hours of intervention delivered over a period of 6-8 weeks.
 Assessments at a pre-treatment baseline point, 8 weeks (immediately post-treatment), and
 6 months will cover the following domains: a) patients' demographic characteristics and
 clinical functioning, b) self-care, including self-management of symptoms, knowledge of
 HF, and adherence to medication and dietary intake of sodium, c) measures of family
 functioning relevant to the medical care of the patient, and d) health care utilization
 costs. Primary outcome measures will be patients' self-reported HF self-care and health
 care utilization costs. We anticipate that patients in the FPI condition will exhibit
 better self-care over time compared to patients in the WL condition. We also anticipate
 that patients and family members will exhibit an improved family environment and better
 HF knowledge.
Inclusion Criteria:

 1. 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.

 2. 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.

 3. 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).

 4. Subjects are able to give informed consent (see below for exclusion due to
 well-documented dementia or evidence of cognitive impairment).

 5. 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 Criteria:

 1. Patient has a well-documented diagnosis of dementia

 2. Moderate or greater cognitive impairment, based on the Blessed Test of Orientation,
 Memory, and Concentration (BOMC)[26] score of 16.

 3. Patient's family member has BOMC score of 10 (i.e., mild or greater cognitive
 impairment).

 4. Inability to communicate verbally, major visual impairment, uncorrected hearing loss.

 5. 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]

 6. Patient or family member has a current diagnosis of schizophrenia spectrum psychiatric
 disorder (e.g., schizophrenia, schizoaffective disorder).

 7. Patient indicates active suicidal ideation and evaluated as a clinical risk.

 8. Patient is in the Philadelphia VAMC home-telehealth program or some other incompatible
 intervention.

 9. Patient has an unstable medical condition that would likely prevent the subject from
 completing the study.