Project Fluido: Fluid Watchers

A Self-Care Intervention for Hispanic Patients With Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: PsychoEducational Support

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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	Behavioral: Usual Care; Standard Heart Failure Care
Experimental: Psychoeducational Counseling; 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.	Behavioral: PsychoEducational Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Self-Care Heart Failure Index	Self-Care maintenance, management and confidence will be measured.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression as measured by the Patient Health Questionnaire.	The Patient Health Questionnaire will screen for depression symptoms.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety as measured by the Symptom Inventory Questionnaire	A questionnaire will be used to measure symptoms of anxiety.	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Jill N Howie-Esquivel, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 22, 2014
• Study Completion (Actual): December 22, 2014

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Spanish; Self-care; Congestive Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 10-05030; 69344 (Other Identifier: Robert Wood Johnson Foundation)