Overview

This trial is active, not recruiting.

Condition congestive heart failure
Treatments psychoeducational support, usual care
Sponsor University of California, San Francisco
Start date June 2013
End date December 2014
Trial size 42 participants
Trial identifier NCT02083744, 10-05030, 69344

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Active Comparator)
Usual care group - patients will receive scales to take home and heart failure literature for self-monitoring of heart failure. Patients will complete final questionnaires
usual care
Standard Heart Failure Care
(Experimental)
1-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.
psychoeducational support

Primary Outcomes

Measure
the Self-Care Heart Failure Index
time frame: 3 months

Secondary Outcomes

Measure
Depression as measured by the Patient Health Questionnaire.
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Self-Care Intervention for Hispanic Patients With Heart Failure
Principal investigator Jill N Howie-Esquivel, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.