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Clinical Trials/NCT00205153
NCT00205153
Completed
Not Applicable

A Team Model of Hypertension Care in African Americans

University of Wisconsin, Madison2 sites in 1 country576 target enrollmentDecember 2006
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Wisconsin, Madison
Enrollment
576
Locations
2
Primary Endpoint
Proportion of patients achieving hypertension control
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This Team Education and Adherence Monitoring (TEAM) trial will evaluate the cost-effectiveness of a pharmacy-based intervention in a randomized controlled trial involving 597 treated hypertensive African American patients in five Wisconsin cities. The study involves 28 community pharmacies (14 intervention, 14 control) owned by two pharmacy corporations. Intervention pharmacists and pharmacy technicians implemented a 6-month blood pressure (BP) monitoring program that involved working together as a team with patients and their physicians to achieve improved medication adherence, healthy lifestyles, drug therapy, and hypertension control.

Detailed Description

Researchers screened and enrolled 20-25 subjects in each study pharmacy. Intervention pharmacists and technicians attended a 7-hour TEAM training program on BP monitoring, JNC 7 guidelines, and specially designed tools for assessing and improving medication adherence, lifestyle, patient scheduling and retention, and collaboration with physicians. Intervention teams received specially designed tools, automatic BP monitors, and furniture for setting up and implementing a blood pressure clinic at their pharmacy. Staff from control pharmacies received printed information only and provided "usual care". Outcomes will be determined by blinded data collectors who will re-check patients' BPs and administer follow-up surveys after 6 and 12 months. Researchers also will survey pharmacy staff and review pharmacy records to determine changes in refill adherence and prescribing.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
February 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • is African American and 18 years old or older; has active prescription for BP drug; obtains all BP drugs at the study pharmacy; is able to read and fill out short questionnaires; is able to come to pharmacy for 6 monthly pharmacy visits if needed; has screening BP between 140/90 mm Hg and 210/115 mm Hg.

Exclusion Criteria

  • history of organ transplant or kidney dialysis, symptoms of advanced congestive heart failure, memory impairment that interferes with daily functioning,terminal illness,pregnancy, alcohol or substance abuse problem,physician recommendation of exclusion for other condition that may require special care or limit participation in the study.

Outcomes

Primary Outcomes

Proportion of patients achieving hypertension control

Time Frame: 6 months after enrollment

change in systolic and diastolic blood pressure

Time Frame: 6 months after enrollment

Secondary Outcomes

  • patient adherence to drug regimen(6 months after enrollment)
  • pharmacist adherence to TEAM protocol (intervention fidelity)(6 months after enrollment)
  • change in drug prescribing(6 months after enrollment)
  • patient-reported barriers to adherence (e.g. bothersome side effects)(6 months after enrollment)
  • cost-effectiveness of pharmacy intervention(6 months after intervention)

Study Sites (2)

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