A Team Model of Hypertension Care in African Americans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205153
First received: September 13, 2005
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

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 Intervention
Hypertension
Behavioral: Pharmacy TEAM monitoring and counseling
Other: Usual care with printed information only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Team Model of Hypertension Care in African Americans

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Proportion of patients achieving hypertension control [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
  • change in systolic and diastolic blood pressure [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient adherence to drug regimen [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
  • pharmacist adherence to TEAM protocol (intervention fidelity) [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
  • change in drug prescribing [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
  • patient-reported barriers to adherence (e.g. bothersome side effects) [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]
  • cost-effectiveness of pharmacy intervention [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Usual care with printed information only
Pharmacy staff, patients, and physicians receive printed information only. Patients receive "usual care" from pharmacy staff.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00205153

Locations
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
Investigators
Principal Investigator: Bonnie L Svarstad, PhD University of Wisconsin, Madison
  More Information

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bonnie L. Svarstad, Ph.D., University of Wisconsin - Madison, School of Pharmacy
ClinicalTrials.gov Identifier: NCT00205153     History of Changes
Other Study ID Numbers: M-2000-0284, NIH R01 HL78580
Study First Received: September 13, 2005
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014