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Completed

NCT Number: NCT00205153

A Team Model of Hypertension Care in African Americans

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin School of Pharmacy, Madison, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacy TEAM monitoring and counseling

Behavioral

Pharmacy team monitors and counsels patient using automatic BP monitors and special TEAM tools for assessing and improving patient adherence, barriers to adherence, lifestyle, drug therapy, BP control, and collaboration with physicians.

Primary outcomes

  1. Proportion of patients achieving hypertension control

    Time frame: 6 months after enrollment

  2. change in systolic and diastolic blood pressure

    Time frame: 6 months after enrollment

Secondary outcomes

  1. patient adherence to drug regimen

    Time frame: 6 months after enrollment

  2. pharmacist adherence to TEAM protocol (intervention fidelity)

    Time frame: 6 months after enrollment

  3. change in drug prescribing

    Time frame: 6 months after enrollment

  4. patient-reported barriers to adherence (e.g. bothersome side effects)

    Time frame: 6 months after enrollment

  5. cost-effectiveness of pharmacy intervention

    Time frame: 6 months after intervention

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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