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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

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

Study Type : Interventional  (Clinical Trial)
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 2008
Primary Completion Date : December 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Greater reduction in CHD risk in case group vs. control [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 5mm reduction in systolic blood pressure in case group [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948714     History of Changes
Other Study ID Numbers: 808214
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Cardiovascular Diseases