A Team Model of Hypertension Care in African Americans
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
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| United States, Wisconsin | |
| University of Wisconsin School of Pharmacy | |
| Madison, Wisconsin, United States, 53705 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States | |
| Principal Investigator: | Bonnie L Svarstad, PhD | University of Wisconsin, Madison |
More Information
No publications provided
| 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 May 23, 2013