Project Fluido: Fluid Watchers

Not Applicable

Completed

• Conditions: Congestive Heart Failure

• 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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-11
• Primary Completion: 2014-12-22
• Study Completion: 2014-12-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

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

Exclusion Criteria

• live in a nursing home or institution,
• age less than 18
• cognitive deficits
• serious life-limiting co-morbidity such as active cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the Self-Care Heart Failure Index	3 months	Self-Care maintenance, management and confidence will be measured.

Secondary Outcome Measures

Name	Time	Method
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