Project Fluido: Fluid Watchers
This trial is active, not recruiting.
|Condition||congestive heart failure|
|Treatments||psychoeducational support, usual care|
|Sponsor||University of California, San Francisco|
|Start date||June 2013|
|End date||December 2014|
|Trial size||42 participants|
|Trial identifier||NCT02083744, 10-05030, 69344|
The long-term goal of this research is to determine whether a psychoeducational intervention will support self-care behaviors in Hispanic patients with heart failure. The specific goal of this study is to determine whether a culturally-appropriate psychoeducational intervention in Hispanic patients with heart failure, compared to a control group, will improve heart failure knowledge and self-care behaviors.
We hypothesize that patients who receive the intervention will have improved heart failure self-care behaviors and depression scores as measured by the Self-Care Heart Failure Index and Patient Health Questionnaire.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
|Primary purpose||supportive care|
the Self-Care Heart Failure Index
time frame: 3 months
Depression as measured by the Patient Health Questionnaire.
time frame: 3 months
Male or female participants at least 18 years old.
- have been hospitalized for heart failure within the previous 24 months
- identify themselves as Hispanic in origin
- speak and write in Spanish or English
- live in a nursing home or institution,
- age less than 18
- cognitive deficits
- serious life-limiting co-morbidity such as active cancer
|Official title||A Self-Care Intervention for Hispanic Patients With Heart Failure|
|Principal investigator||Jill N Howie-Esquivel, PhD|
|Description||A randomized clinical trial research design is planned. Investigators will obtain baseline and final measures on the intervention and control groups. A sample of 60 adult Hispanic heart failure patients will be recruited. Each patient will either participate in the psychoeducational intervention or usual care. A repeated measures (longitudinal) analysis will be used to examine these aims by employing a linear mixed models approach. The basic analysis has one between subjects (fixed) factor, group, with 2 levels (education and control) and one repeated factor, time, with 2 levels (baseline and 12 months). This analysis allows for testing the main effect of group, main effect of time, and the group by time interaction. The potential benefit of improving heart failure knowledge and self-care in Hispanic heart failure patients is that these patients may better understand how to care for themselves. This study will provide data to examine the longer-term outcomes of emergency department visits and hospitalization events in Hispanic patients.|
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