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Completed

NCT Number: NCT02340364

Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease

The investigators are asking subjects to take part in the Patient NAVIgation to Reduce Readmissions among Black Men with Heart Disease (NAVI-HF) research study. This research study will test how well trained laypeople working as patient navigators will help patients recently hospitalized for heart failure avoid future hospitalizations. NAVI-HF is a new program sponsored by funding from the National Institute of Minority Health and Health Disparities. People who enter into the study will work with a patient navigator to undergo the full program or work with a trained layperson to receive general education on heart disease treatment and prevention. The purpose of the study is to determine whether a patient navigation program will be effective in reducing the number of hospitalizations in the future for program participants. This study will enroll 416 participants from UAB.

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Key information

Age range

30 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UAB Medical West, Bessemer, Alabama, United States

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About this study

Therefore, in the Patient NAVIgation to Reduce Readmissions among Black Men with Heart Disease (NAVI-HF) study, the investigators propose to recruit 416 AA men with Heart Disease receiving inpatient care at UAB Hospital and randomize them either to Heart Disease self-care education plus a patient navigator-delivered self-care plan (Education + PN arm) or to Heart Disease self-care education alone (Educational Control arm). The investigators will compare participant outcomes such as all-cause and Heart Disease readmission rates, Heart Disease self-care adherence as well as cost effectiveness across the two intervention arms. Our Specific Aims are:

  • To assess the 30-day all-cause readmission rates among male African American Heart Disease patients receiving Heart Disease self-care education plus a patient navigator-delivered self-care plan versus Heart Disease self-care education alone
  • To assess the Heart Disease self-efficacy and heart failure self-care adherence among male African American Heart Disease patients receiving Heart Disease self-care education plus a patient navigator-delivered self-care plan versus Heart Disease self-care education alone
  • To evaluate the cost-effectiveness of Heart Disease self-care education plus a patient navigator-delivered self-care plan versus Heart Disease self-care education alone

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • African American
  • Male
  • Age = 30 or older
  • Inpatient admission at UAB Hospital or UAB Medical West with a diagnosis of heart disease as a principle or one of the first 3 diagnosis.
  • Residence in Jefferson or Shelby Counties, Alabama within 45 miles of UAB Hospital.
  • English Speaking
  • Physically and cognitively able to listen to 30-minute video undergo a home visit and telephone contacts over several weeks.

Exclusion criteria

  • Heart transplant or awaiting heart transplant (admitted to UAB Advanced HF/Transplant Service).
  • Currently participating in another clinical research study with an overlapping intervention.
  • Current or anticipated long term (>2 weeks) residence in a skilled nursing facility.
  • Patients who indicated that they were unwilling to make lifestyle changes now or in the near future.
  • Patients whose symptoms may be eliminated by surgery (e.g., severe aortic stenosis) or who had undergone surgery (e.g., coronary artery bypass grafting valvular replacement/repair) in the last month.

Treatment and study plan

Education + Patient Navigation

Behavioral

208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.

Self-care education

Behavioral

208 patients randomized to self-care education alone.

Primary outcomes

  1. Readmission Rates

    Time frame: Within 30 days

    Re-hospitalization of Heart Disease patients within 30 days of being discharged home.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: NAVI-HF

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2015
Registry last updated
Jul 31, 2019

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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