Clinical trial NCT02083744: Project Fluido: Fluid Watchers
Official title: A Self-Care Intervention for Hispanic Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Self-care
Spanish
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: the Self-Care Heart Failure Index
timeFrame: 3 months
Secondary outcomes:
measure: Depression as measured by the Patient Health Questionnaire.
timeFrame: 3 months
Other outcomes:
measure: Anxiety as measured by the Symptom Inventory Questionnaire
timeFrame: 3 months
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jill N Howie-Esquivel, PhD
role: PRINCIPAL_INVESTIGATOR
References: