Support for Cardiovascular Health in African American Primary Care Patients

NCT00948714 | Completed DMC

• 1 other identifier: 808214
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Blood Pressure

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• 5mm reduction in systolic blood pressure in case group

  6 months

Study Arms (2)

Case

EXPERIMENTAL

Behavioral: Peer Coach Phone Calls; Behavioral: Health Educator Visits; Other: written materials

Control

ACTIVE COMPARATOR

Other: written materials

Interventions

Peer Coach Phone Calls BEHAVIORAL

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

Case

Health Educator Visits BEHAVIORAL

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

Case

written materials OTHER

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

Case; Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American
• Uncontrolled Hypertension
• at least 3 practice visits in the past 2 years
• One lipid panel since 2005

You may not qualify if:

• No recent lipid panel
• Kept less than 60% of primary care visits in the prior 2 years

Sponsors & Collaborators

• University of Pennsylvania: lead
• Robert Wood Johnson Foundation: collaborator
• Pfizer: collaborator

Study Sites (2)

Edward S. Cooper Practice of General Internal Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

PennCare Internal Medicine Associates

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 22570108 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Mark G Weiner, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (2)