Project Fluido: Fluid Watchers
A Self-Care Intervention for Hispanic Patients With Heart Failure
2 other identifiers
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2014
CompletedFebruary 17, 2020
February 1, 2020
1.6 years
February 25, 2014
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the Self-Care Heart Failure Index
Self-Care maintenance, management and confidence will be measured.
3 months
Secondary Outcomes (1)
Depression as measured by the Patient Health Questionnaire.
3 months
Other Outcomes (1)
Anxiety as measured by the Symptom Inventory Questionnaire
3 months
Study Arms (2)
Control Group
ACTIVE COMPARATORUsual care group - patients will receive scales to take home and heart failure literature for self-monitoring of heart failure. Patients will complete final questionnaires
Psychoeducational Counseling
EXPERIMENTAL1-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.
Interventions
Eligibility Criteria
You may qualify if:
- have been hospitalized for heart failure within the previous 24 months
- identify themselves as Hispanic in origin
- speak and write in Spanish or English
You may not qualify if:
- live in a nursing home or institution,
- age less than 18
- cognitive deficits
- serious life-limiting co-morbidity such as active cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill N Howie-Esquivel, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
March 11, 2014
Study Start
June 1, 2013
Primary Completion
December 22, 2014
Study Completion
December 22, 2014
Last Updated
February 17, 2020
Record last verified: 2020-02