Clinical Trials Directory

Trials / Completed

CompletedNCT02083744

Project Fluido: Fluid Watchers

A Self-Care Intervention for Hispanic Patients With Heart Failure

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPsychoEducational Support
BEHAVIORALUsual CareStandard Heart Failure Care

Timeline

Start date
2013-06-01
Primary completion
2014-12-22
Completion
2014-12-22
First posted
2014-03-11
Last updated
2020-02-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02083744. Inclusion in this directory is not an endorsement.