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Health Promoters and Pharmacists in Diabetes Team Management

Health Promoters and Pharmacists in Diabetes Team Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01498159
Enrollment
244
Registered
2011-12-23
Start date
2011-12-31
Completion date
2018-01-31
Last updated
2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus, Pharmacists, Community Health Aides

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPharmacist disease/medication management
BEHAVIORALPharmacist-patient encounters
BEHAVIORALPharmacist medication intensification and adherence support
BEHAVIORALPharmacist communication with primary care physicians
BEHAVIORALPharmacist documentation in electronic medical record
BEHAVIORALHealth promoter-patient encounters in-person or by phone
BEHAVIORALHealth promoter medication and lifestyle support
BEHAVIORALHealth promoter communication with pharmacists

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1c24 monthsHemoglobin A1c

Secondary

MeasureTime frameDescription
Autonomous Self-Regulation24 monthsAutonomous Self-Regulation
Perceived Competence24 monthsPerceived Competence
Medication Adherence24 monthsMedication Adherence
Body mass index24 monthsBody mass index
Diabetes Self-Care Behaviors24 monthsDiabetes Self-Care Behaviors
Diabetes Knowledge24 monthsDiabetes Knowledge
Healthcare Utilization24 monthsHealthcare Utilization
Systolic Blood Pressure24 monthsSystolic Blood Pressure
Diastolic Blood Pressure24 monthsDiastolic Blood Pressure
LDL Cholesterol24 monthsLDL Cholesterol
Quality of Life24 monthsQuality of Life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026