Health Promoters and Pharmacists in Diabetes Team Management



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:5/5/2018
Start Date:December 2011
End Date:January 2018

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This research evaluates a diabetes management intervention designed to improve medication
adherence and intensify therapy to reach goals in blood sugar, blood pressure, and
cholesterol levels. This study will determine the benefit and cost of adding community health
promoters to pharmacist disease management services. If there is benefit, then this approach
may help reduce the burden of diabetes and its related complications among minorities with
diabetes.

Many African-Americans and Latinos with diabetes do not achieve the recommended goals for
normal blood sugar, blood pressure, or cholesterol level, placing them at high risk for
complications. This study will evaluate the impact of a novel intervention designed to
improve lifestyle behaviors and medication adherence, and intensify therapy to reach goals.
The first component of the intervention includes a clinic-based pharmacist disease management
program. The program includes detailed patient assessments, physician-approved treatment
plans, patient education and support services to enhance medication adherence. In addition,
this program includes intensification of medication therapy to improve blood sugar, blood
pressure, and cholesterol levels to reach recommended goals. The second component of the
intervention includes health promoters (HPs), or community-based lay health workers. Health
promoters are commonly found in minority communities and provide assistance for individuals
overcoming language, cultural, and other barriers to conventional health care services. They
may provide autonomy support and solve problems related to medication adherence barriers.
Furthermore, health promoters may complement pharmacist activities by improving access to
medications, assisting in continuity of care with providers, monitoring response to therapy,
and reinforcing educational messages. The proposed study will determine whether the addition
of health promoters to clinic based pharmacist service delivery improves care. The study will
involve the recruitment of 300 African-American and Latino adults with uncontrolled diabetes
through the University of Illinois Medical Center in Chicago and randomization to one of two
groups: (1) pharmacist management (Pharm) for 12 months; or (2) pharmacist management with HP
support (Pharm+HP) for 12 months. Cross-over will occur at 12 months such that the Pharm
group will be intensified by the addition of HP support and HP support will be phased out
from the Pharm+HP group to assess maintenance. The specific aims include: (1) To evaluate the
effectiveness of Pharm+HP compared with Pharm alone on diabetes behaviors (including healthy
eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and
LDL-cholesterol levels; (2) To evaluate the maintenance of improved diabetes behaviors as
well as clinical outcomes by phasing out HP support from the Pharm+HP group after year 1; (3)
To evaluate the intensification offered by adding an HP after one year of Pharm alone; and
(4) To evaluate the cost and cost-effectiveness of Pharm+HP and Pharm alone.

Inclusion Criteria:

- Self-identified as Latino/Hispanic or African-American

- Verbal fluency in English or Spanish

- Age 21 or above

- History of type 2 diabetes (> 1 year)

- Hemoglobin A1c ≥ 8.0% (within 1 year)

- Receives primary care at UIMC (> 1 year)

- Taking at least one oral medication for diabetes or hypertension

Exclusion Criteria:

- Unable to verbalize comprehension of study or impaired decision making (e.g.,
dementia)

- Lives outside Chicago communities of recruitment (3+ months/year)

- Household member already participating in same study

- Plans to move from the Chicago area within the next year

- Pregnant or trying to get pregnancy
We found this trial at
1
site
Chicago, Illinois 60612
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from
Chicago, IL
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