A Team Model of Hypertension Care in African Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00205153
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 23, 2014
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Pharmacy TEAM monitoring and counseling Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Team Model of Hypertension Care in African Americans
Study Start Date : December 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TEAM Care
Intervention pharmacies implement 6-month TEAM program.
Behavioral: Pharmacy TEAM monitoring and counseling
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.

No Intervention: Usual Care
Control pharmacies provide "usual care" only.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00205153

United States, Wisconsin
University of Wisconsin School of Pharmacy
Madison, Wisconsin, United States, 53705
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
Principal Investigator: Bonnie L Svarstad, PhD University of Wisconsin, Madison

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison Identifier: NCT00205153     History of Changes
Other Study ID Numbers: M-2000-0284
NIH R01 HL78580
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by University of Wisconsin, Madison:
hypertension in African Americans

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases