Support for Cardiovascular Health in African American Primary Care Patients

This study has been completed.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Pfizer
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948714
First received: July 28, 2009
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Blood Pressure
Behavioral: Peer Coach Phone Calls
Behavioral: Health Educator Visits
Other: written materials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Greater reduction in CHD risk in case group vs. control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 5mm reduction in systolic blood pressure in case group [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: May 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Case 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
Active Comparator: Control Other: written materials
Subjects will receive written material and brochures and a cookbook from the American Heart Association addressing healthy lifestyle

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948714

Locations
United States, Pennsylvania
Edward S. Cooper Practice of General Internal Medicine
Philadelphia, Pennsylvania, United States, 19104
PennCare Internal Medicine Associates
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Robert Wood Johnson Foundation
Pfizer
Investigators
Principal Investigator: Mark G Weiner, MD University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Barbara J Turner, University of Pennsylvania School of Medicine
ClinicalTrials.gov Identifier: NCT00948714     History of Changes
Other Study ID Numbers: 808214
Study First Received: July 28, 2009
Last Updated: June 3, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014