Support for Cardiovascular Health in African American Primary Care Patients

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00948714
Collaborator
Robert Wood Johnson Foundation (Other), Pfizer (Industry)
130
2
2
32
65
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Coach Phone Calls
  • Behavioral: Health Educator Visits
  • Other: written materials
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Greater reduction in CHD risk in case group vs. control [6 months]

Secondary Outcome Measures

  1. 5mm reduction in systolic blood pressure in case group [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Edward S. Cooper Practice of General Internal Medicine Philadelphia Pennsylvania United States 19104
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948714
Other Study ID Numbers:
  • 808214
First Posted:
Jul 29, 2009
Last Update Posted:
Jul 21, 2017
Last Verified:
Jul 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2017