Project Fluido: Fluid Watchers

Congestive Heart Failure Clinical Trial

Official title:

A Self-Care Intervention for Hispanic Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083744
• Other study ID #: 10-05030
• Secondary ID: 69344
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 22, 2014

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 22, 2014
• Est. primary completion date: December 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Behavioral:
• PsychoEducational Support

• Usual Care
Standard Heart Failure Care

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety as measured by the Symptom Inventory Questionnaire	A questionnaire will be used to measure symptoms of anxiety.	3 months
Primary	the Self-Care Heart Failure Index	Self-Care maintenance, management and confidence will be measured.	3 months
Secondary	Depression as measured by the Patient Health Questionnaire.	The Patient Health Questionnaire will screen for depression symptoms.	3 months