Clinical trial NCT00645489: A Family Intervention for Improving Self-Care of Patients With Heart Failure
Official title: A Family Intervention for Improving Self-Care of Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Heart Failure, Congestive
Keywords: heart failure intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: dietary sodium intake
timeFrame: 6 months
Secondary outcomes:
measure: medication adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: VA Medical Center, Philadelphia
state: Pennsylvania
Study officials:
affiliation: VA Medical Center, Philadelphia
name: Steven L. Sayers, PhD
role: PRINCIPAL_INVESTIGATOR
References: