Support for Cardiovascular Health in African American Primary Care Patients

Cardiovascular Diseases Clinical Trial

Official title:

Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948714
• Other study ID #: 808214
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: July 19, 2017
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: July 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases

Intervention

Behavioral:
• Peer Coach Phone Calls
Subjects will receive 3 phone calls from a trained peer coach over 6 months.
• 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

Locations

Country	Name	City	State
United States	Edward S. Cooper Practice of General Internal Medicine	Philadelphia	Pennsylvania
United States	PennCare Internal Medicine Associates	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Pfizer, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Greater reduction in CHD risk in case group vs. control		6 months
Secondary	5mm reduction in systolic blood pressure in case group		6 months