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OpenTrials
Completed

NCT Number: NCT00948714

Support for Cardiovascular Health in African American Primary Care Patients

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward S. Cooper Practice of General Internal Medicine, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Coach Phone Calls

Behavioral

Subjects will receive 3 phone calls from a trained peer coach over 6 months.

Health Educator Visits

Behavioral

Subjects will meet 2 times with a trained health educator in the practice

written materials

Other

Subjects will receive written material and brochures and a cookbook from the American Heart Association addressing healthy lifestyle

Primary outcomes

  1. Greater reduction in CHD risk in case group vs. control

    Time frame: 6 months

Secondary outcomes

  1. 5mm reduction in systolic blood pressure in case group

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Pfizer
  • Robert Wood Johnson Foundation

Registry information

Official study title

Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jul 29, 2009
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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