Support for Cardiovascular Health in African American Primary Care Patients

Not Applicable

Completed

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

• Registration Number: NCT00948714
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case	Health Educator Visits	-
Case	Peer Coach Phone Calls	-
Case	written materials	-
Control	written materials	-

Primary Outcome Measures

Name	Time	Method
Greater reduction in CHD risk in case group vs. control	6 months

Secondary Outcome Measures

Name	Time	Method
5mm reduction in systolic blood pressure in case group	6 months

Trial Locations

Locations (2)

PennCare Internal Medicine Associates; 🇺🇸 Philadelphia, Pennsylvania, United States

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