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Completed

NCT Number: NCT02083744

Project Fluido: Fluid Watchers

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducational Support

Behavioral

Usual Care

Behavioral

Standard Heart Failure Care

Primary outcomes

  1. the Self-Care Heart Failure Index

    Time frame: 3 months

    Self-Care maintenance, management and confidence will be measured.

Secondary outcomes

  1. Depression as measured by the Patient Health Questionnaire.

    Time frame: 3 months

    The Patient Health Questionnaire will screen for depression symptoms.

Other outcomes

  1. Anxiety as measured by the Symptom Inventory Questionnaire

    Time frame: 3 months

    A questionnaire will be used to measure symptoms of anxiety.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

A Self-Care Intervention for Hispanic Patients With Heart Failure

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2014
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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