Project Fluido: Fluid Watchers
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|ClinicalTrials.gov Identifier: NCT02083744|
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 17, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- the Self-Care Heart Failure Index [ Time Frame: 3 months ]Self-Care maintenance, management and confidence will be measured.
- Depression as measured by the Patient Health Questionnaire. [ Time Frame: 3 months ]The Patient Health Questionnaire will screen for depression symptoms.
- Anxiety as measured by the Symptom Inventory Questionnaire [ Time Frame: 3 months ]A questionnaire will be used to measure symptoms of anxiety.
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 ClinicalTrials.gov identifier (NCT number): NCT02083744
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Jill N Howie-Esquivel, PhD||University of California, San Francisco|