Support for Cardiovascular Health in African American Primary Care Patients

• ClinicalTrials.gov Identifier: NCT00948714
• Recruitment Status: Completed
• First Posted: July 29, 2009
• Last Update Posted: July 21, 2017
• Sponsor: University of Pennsylvania
• Collaborators: Robert Wood Johnson Foundation; Pfizer
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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	Phase
Cardiovascular Diseases; Blood Pressure	Behavioral: Peer Coach Phone Calls; Behavioral: Health Educator Visits; Other: written materials	Not Applicable

Study Design

• 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
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: January 2011

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• 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

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2012 May 9.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00948714
• Other Study ID Numbers: 808214
• First Posted: July 29, 2009
• Last Update Posted: July 21, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Cardiovascular Diseases