Support for Cardiovascular Health in African American Primary Care Patients
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Purpose
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 | Intervention |
|---|---|
|
Cardiovascular Diseases Blood Pressure |
Behavioral: Peer Coach Phone Calls Behavioral: Health Educator Visits Other: written materials |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients |
- Greater reduction in CHD risk in case group vs. control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 5mm reduction in systolic blood pressure in case group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | May 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| 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 | |
| Principal Investigator: | Mark G Weiner, MD | University of Pennsylvania |
More Information
No publications provided by University of Pennsylvania
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Barbara J Turner, University of Pennsylvania School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00948714 History of Changes |
| Other Study ID Numbers: | 808214 |
| Study First Received: | July 28, 2009 |
| Last Updated: | June 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013