An interventional study of PsychoEducational Support and Usual Care in Congestive Heart Failure, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
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.
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.
5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 42 is below the median of 72 across 3,737 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of California, San Francisco is the lead sponsor of 2,133 studies on the registry; 376 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Usual care group - patients will receive scales to take home and heart failure literature for self-monitoring of heart failure. Patients will complete final questionnaires
Behavioral: Usual Care
1-on-1 psychoeducation session conducted by a bilingual research nurse at the clinic site or in the patient's home. Patients will receive a scale to measure weight, a diary to record weight and symptoms of heart failure, and telephone follow-up from the research nurse to reinforce the content of the education program every other week. Focus-groups - Perception of the intervention will be assessed with two focus groups.
Behavioral: PsychoEducational Support
Standard Heart Failure Care
the Self-Care Heart Failure Index
Self-Care maintenance, management and confidence will be measured.
Time frame: 3 months
Depression as measured by the Patient Health Questionnaire.
The Patient Health Questionnaire will screen for depression symptoms.
Time frame: 3 months
Anxiety as measured by the Symptom Inventory Questionnaire
A questionnaire will be used to measure symptoms of anxiety.
Time frame: 3 months
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco