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Project Fluido: Fluid Watchers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02083744
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Behavioral: PsychoEducational Support Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Self-Care Intervention for Hispanic Patients With Heart Failure
Study Start Date : June 2013
Actual Primary Completion Date : December 22, 2014
Actual Study Completion Date : December 22, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

Primary Outcome Measures :
  1. the Self-Care Heart Failure Index [ Time Frame: 3 months ]
    Self-Care maintenance, management and confidence will be measured.

Secondary Outcome Measures :
  1. Depression as measured by the Patient Health Questionnaire. [ Time Frame: 3 months ]
    The Patient Health Questionnaire will screen for depression symptoms.

Other Outcome Measures:
  1. Anxiety as measured by the Symptom Inventory Questionnaire [ Time Frame: 3 months ]
    A questionnaire will be used to measure symptoms of anxiety.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02083744

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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Jill N Howie-Esquivel, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT02083744    
Other Study ID Numbers: 10-05030
69344 ( Other Identifier: Robert Wood Johnson Foundation )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Keywords provided by University of California, San Francisco:
Congestive Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases