ClinicalTrials.Veeva

Menu

Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease (NAVI-HF)

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Heart Diseases

Treatments

Behavioral: Education + Patient Navigation
Behavioral: Self-care Education

Study type

Interventional

Funder types

Other

Identifiers

NCT02340364
X130515002

Details and patient eligibility

About

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.

Full description

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:

  1. 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
  2. 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
  3. 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

Enrollment

301 patients

Sex

Male

Ages

30 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

301 participants in 2 patient groups

Education + PN Arm
Experimental group
Description:
208 patients randomized to self-care education+ Patient navigator-delivered self-care plan.
Treatment:
Behavioral: Education + Patient Navigation
Educational Control Arm
Active Comparator group
Description:
- 208 patients randomized to self-care education alone.
Treatment:
Behavioral: Self-care Education

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems