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Project Fluido: Fluid Watchers

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PsychoEducational Support
Usual Care
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Self-care, Spanish

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Psychoeducational Counseling

Arm Description

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

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.

Outcomes

Primary Outcome Measures

the Self-Care Heart Failure Index
Self-Care maintenance, management and confidence will be measured.

Secondary Outcome Measures

Depression as measured by the Patient Health Questionnaire.
The Patient Health Questionnaire will screen for depression symptoms.

Full Information

First Posted
February 25, 2014
Last Updated
February 13, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02083744
Brief Title
Project Fluido: Fluid Watchers
Official Title
A Self-Care Intervention for Hispanic Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 22, 2014 (Actual)
Study Completion Date
December 22, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive Heart Failure, Self-care, Spanish

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Psychoeducational Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PsychoEducational Support
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Standard Heart Failure Care
Primary Outcome Measure Information:
Title
the Self-Care Heart Failure Index
Description
Self-Care maintenance, management and confidence will be measured.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Depression as measured by the Patient Health Questionnaire.
Description
The Patient Health Questionnaire will screen for depression symptoms.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Anxiety as measured by the Symptom Inventory Questionnaire
Description
A questionnaire will be used to measure symptoms of anxiety.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill N Howie-Esquivel, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Project Fluido: Fluid Watchers

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