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Project Fluido: Fluid Watchers

Not Applicable
Completed
Conditions
Congestive Heart Failure
Interventions
Behavioral: PsychoEducational Support
Behavioral: Usual Care
Registration Number
NCT02083744
Lead Sponsor
University of California, San Francisco
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
Inclusion Criteria
  • have been hospitalized for heart failure within the previous 24 months
  • identify themselves as Hispanic in origin
  • speak and write in Spanish or English
Read More
Exclusion Criteria
  • live in a nursing home or institution,
  • age less than 18
  • cognitive deficits
  • serious life-limiting co-morbidity such as active cancer
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Psychoeducational CounselingPsychoEducational Support1-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.
Control GroupUsual CareUsual care group - patients will receive scales to take home and heart failure literature for self-monitoring of heart failure. Patients will complete final questionnaires
Primary Outcome Measures
NameTimeMethod
the Self-Care Heart Failure Index3 months

Self-Care maintenance, management and confidence will be measured.

Secondary Outcome Measures
NameTimeMethod
Depression as measured by the Patient Health Questionnaire.3 months

The Patient Health Questionnaire will screen for depression symptoms.

Trial Locations

Locations (1)

University of California San Francisco

🇺🇸

San Francisco, California, United States

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