Support for Cardiovascular Health in African American Primary Care Patients

Peer and Health Educator 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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Blood Pressure
• Intervention / Treatment: Behavioral: Peer Coach Phone Calls; Behavioral: Health Educator Visits; Other: written materials

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Edward S. Cooper Practice of General Internal Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • PennCare Internal Medicine Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control	Other: written materials; Subjects will receive written material and brochures and a cookbook from the American Heart Association addressing healthy lifestyle
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Greater reduction in CHD risk in case group vs. control	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
5mm reduction in systolic blood pressure in case group	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Pfizer; Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Mark G Weiner, MD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: July 28, 2009
• First Submitted That Met QC Criteria: July 28, 2009
• First Posted (ESTIMATE): July 29, 2009

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 808214