Skip to content

Project Fluido: Fluid Watchers

A Self-Care Intervention for Hispanic Patients With Heart Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02083744
Enrollment
42
Registered
2014-03-11
Start date
2013-06-30
Completion date
2014-12-22
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure, Self-care, Spanish

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.

Interventions

BEHAVIORALUsual Care

Standard Heart Failure Care

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the Self-Care Heart Failure Index3 monthsSelf-Care maintenance, management and confidence will be measured.

Secondary

MeasureTime frameDescription
Depression as measured by the Patient Health Questionnaire.3 monthsThe Patient Health Questionnaire will screen for depression symptoms.

Other

MeasureTime frameDescription
Anxiety as measured by the Symptom Inventory Questionnaire3 monthsA questionnaire will be used to measure symptoms of anxiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026