Project Fluido: Fluid Watchers

NCT ID: NCT02083744

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-12-22

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Standard Heart Failure Care

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.

Group Type: EXPERIMENTAL

PsychoEducational Support

Intervention Type: BEHAVIORAL

Interventions

PsychoEducational Support

Intervention Type: BEHAVIORAL

Usual Care

Standard Heart Failure Care

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill N Howie-Esquivel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

69344

Identifier Type: OTHER

Identifier Source: secondary_id

10-05030

Identifier Type: -

Identifier Source: org_study_id