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Support for Cardiovascular Health in African American Primary Care Patients

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ClinicalTrials.gov Identifier: NCT00948714
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Pfizer
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE July 28, 2009
First Posted Date  ICMJE July 29, 2009
Last Update Posted Date July 21, 2017
Study Start Date  ICMJE May 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2009)
Greater reduction in CHD risk in case group vs. control [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2009)
5mm reduction in systolic blood pressure in case group [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Support for Cardiovascular Health in African American Primary Care Patients
Official Title  ICMJE Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients
Brief Summary

Project Overview:

Poor hypertension control has dire consequences for the African-American population who suffer greater death and disability from heart disease, stroke, and renal failure than whites. To reduce these health disparities it is critical to promote of a healthy lifestyle in regard to diet, exercise, adherence to medications, as well as other behaviors. However, physicians usually fail to address lifestyle behaviors in the context of the harried patient visit. Therefore, the investigators hypothesized that the investigators could reduce cardiovascular risk by providing additional support to persons with poorly controlled hypertension through phone calls from trained peer patients and visits to an office support staff member.

Study Design:

A single-blind, randomized, controlled trial in 280 African-American primary care patients aged 40-75 with poorly controlled hypertension (HTN). The intervention group receives a practice-based team intervention that combines peer coach with office staff (i.e., medical assistant or licensed practice nurse) visits to address lifestyle challenges. Both intervention and control groups receive informational materials and healthy soul food recipes from the American Heart Association. The 6 month intervention alternates monthly phone calls from peer coaches about lifestyle behavioral changes with office-based visits with the support staff member during which patients review and discuss low literacy slide shows about healthy behaviors as well as examine their personal cardiovascular risk profile.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cardiovascular Diseases
  • Blood Pressure
Intervention  ICMJE
  • Behavioral: Peer Coach Phone Calls
    Subjects will receive 3 phone calls from a trained peer coach over 6 months.
  • Behavioral: Health Educator Visits
    Subjects will meet 2 times with a trained health educator in the practice
  • Other: written materials
    Subjects will receive written material and brochures and a cookbook from the American Heart Association addressing healthy lifestyle
Study Arms  ICMJE
  • Experimental: Case
    Interventions:
    • Behavioral: Peer Coach Phone Calls
    • Behavioral: Health Educator Visits
    • Other: written materials
  • Active Comparator: Control
    Intervention: Other: written materials
Publications * Turner BJ, Hollenbeak CS, Liang Y, Pandit K, Joseph S, Weiner MG. A randomized trial of peer coach and office staff support to reduce coronary heart disease risk in African-Americans with uncontrolled hypertension. J Gen Intern Med. 2012 Oct;27(10):1258-64. Epub 2012 May 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2017)
130
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2009)
250
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • African American
  • Uncontrolled Hypertension
  • at least 3 practice visits in the past 2 years
  • One lipid panel since 2005

Exclusion Criteria:

  • No recent lipid panel
  • Kept less than 60% of primary care visits in the prior 2 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00948714
Other Study ID Numbers  ICMJE 808214
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • Robert Wood Johnson Foundation
  • Pfizer
Investigators  ICMJE
Principal Investigator: Mark G Weiner, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP