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

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ClinicalTrials.gov Identifier: NCT02340364
Recruitment Status : Recruiting
First Posted : January 16, 2015
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Reagan W. Durant, MD, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Diseases Behavioral: Education + Patient Navigation Behavioral: Self-care Education Not Applicable

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease
Study Start Date : March 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Education + PN Arm
208 patients randomized to self-care education+ Patient navigator-delivered self-care plan.
Behavioral: Education + Patient Navigation
208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.

Active Comparator: Educational Control Arm
- 208 patients randomized to self-care education alone.
Behavioral: Self-care Education
208 patients randomized to self-care education alone.




Primary Outcome Measures :
  1. Readmission Rates [ Time Frame: Within 30 days ]
    Re-hospitalization of Heart Disease patients within 30 days of being discharged home.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT02340364


Contacts
Contact: Billy L Alexander, MSN 205-934-8767 blalexander@uabmc.edu
Contact: Deborah Weber, BSN 205-975-9964 dlowe@uabmc.edu

Locations
United States, Alabama
UAB Medical West Recruiting
Bessemer, Alabama, United States, 35022
Contact: Billy L Alexander, MSN    205-934-8767    blalexander@uabmc.edu   
Contact: Deborah L Weber, BSN    205-975-9964    dlowe@uabmc.edu   
Principal Investigator: Raegan Durant, MD, MPH         
Sub-Investigator: Alexander Lo, MD, PhD         
UAB Recruiting
Birmingham, Alabama, United States, 35294
Contact: Billy L Alexander, MSN    205-934-8767    blalexander@uabmc.edu   
Contact: Deborah Weber, BSN    205-975-9964    dlowe@uabmc.edu   
Principal Investigator: Raegan W Durant, M.D., MPH         
Sub-Investigator: Alexander Lo, M.D., PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Raegan W Durant, M.D., MPH University of Alabama at Birmingham

Responsible Party: Reagan W. Durant, MD, Principal investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02340364     History of Changes
Other Study ID Numbers: X130515002
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

Keywords provided by Reagan W. Durant, MD, University of Alabama at Birmingham:
Hospital Readmissions
Patient Navigation

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases