Support for Cardiovascular Health in African American Primary Care Patients

NCT ID: NCT00948714

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Case

Group Type EXPERIMENTAL

Peer Coach Phone Calls

Intervention Type BEHAVIORAL

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

Health Educator Visits

Intervention Type BEHAVIORAL

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

written materials

Intervention Type OTHER

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

Control

Group Type ACTIVE_COMPARATOR

written materials

Intervention Type OTHER

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

Interventions

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Peer Coach Phone Calls

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

Intervention Type BEHAVIORAL

Health Educator Visits

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

Intervention Type BEHAVIORAL

written materials

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark G Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Edward S. Cooper Practice of General Internal Medicine

Philadelphia, Pennsylvania, United States

Site Status

PennCare Internal Medicine Associates

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22570108 (View on PubMed)

Other Identifiers

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808214

Identifier Type: -

Identifier Source: org_study_id

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