A Family Intervention for Improving Self-Care of Patients With Heart Failure
This study has been completed.
Information provided by:
Department of Veterans Affairs
First received: March 24, 2008
Last updated: January 4, 2010
Last verified: December 2008
This is a pilot study of a family-based educational program for patients with heart failure, and their family members.
Heart Failure, Congestive
Other: wait list
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Family Intervention for Improving Self-Care of Patients With Heart Failure|
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- dietary sodium intake [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Control condition is wait-list control.
Other: wait list
Active treatment condition: psychoeducational intervention for patients with HF
Psychoeducation intervention includes information about self-care of heart failure, and a communication training intervention for patients and family members
- 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.
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645489
|United States, Pennsylvania|
|VA Medical Center, Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
Sponsors and Collaborators
|Principal Investigator:||Steven L. Sayers, PhD||VA Medical Center, Philadelphia|