Health Promoters and Pharmacists in Diabetes Team Management

April 30, 2018 updated by: Ben Gerber, University of Illinois at Chicago
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 24 months
Hemoglobin A1c
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Knowledge
Time Frame: 24 months
Diabetes Knowledge
24 months
Autonomous Self-Regulation
Time Frame: 24 months
Autonomous Self-Regulation
24 months
Perceived Competence
Time Frame: 24 months
Perceived Competence
24 months
Medication Adherence
Time Frame: 24 months
Medication Adherence
24 months
Body mass index
Time Frame: 24 months
Body mass index
24 months
Diabetes Self-Care Behaviors
Time Frame: 24 months
Diabetes Self-Care Behaviors
24 months
Quality of Life
Time Frame: 24 months
Quality of Life
24 months
Healthcare Utilization
Time Frame: 24 months
Healthcare Utilization
24 months
Systolic Blood Pressure
Time Frame: 24 months
Systolic Blood Pressure
24 months
Diastolic Blood Pressure
Time Frame: 24 months
Diastolic Blood Pressure
24 months
LDL Cholesterol
Time Frame: 24 months
LDL Cholesterol
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-0099
  • R01DK091347 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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