A Family Intervention for Improving Self-Care of Patients With Heart Failure
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|ClinicalTrials.gov Identifier: NCT00645489|
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : January 6, 2010
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Behavioral: psychoeducational Other: wait list||Early Phase 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Family Intervention for Improving Self-Care of Patients With Heart Failure|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||December 2009|
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
- dietary sodium intake [ Time Frame: 6 months ]
- medication adherence [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645489
|United States, Pennsylvania|
|VA Medical Center, Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Steven L. Sayers, PhD||VA Medical Center, Philadelphia|