NCT00645489

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
BEHAVIORAL	psychoeducational	Psychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members
OTHER	wait list	Wait list

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-03-01
• Completion: 2009-12-01
• First posted: 2008-03-27
• Last updated: 2010-01-06

Locations

1 site across 1 country: United States