Clinical trial NCT00948714: Support for Cardiovascular Health in African American Primary Care Patients
Official title: Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Blood Pressure
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Pfizer
First posted: 2009-07-29
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Greater reduction in CHD risk in case group vs. control
timeFrame: 6 months
Secondary outcomes:
measure: 5mm reduction in systolic blood pressure in case group
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Edward S. Cooper Practice of General Internal Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: PennCare Internal Medicine Associates
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mark G Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/s11606-012-2095-4. Epub 2012 May 9.