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Completed

NCT Number: NCT01498159

Health Promoters and Pharmacists in Diabetes Team Management

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist disease/medication management

Behavioral

Pharmacist-patient encounters

Behavioral

Pharmacist medication intensification and adherence support

Behavioral

Pharmacist communication with primary care physicians

Behavioral

Pharmacist documentation in electronic medical record

Behavioral

Health promoter-patient encounters in-person or by phone

Behavioral

Health promoter medication and lifestyle support

Behavioral

Health promoter communication with pharmacists

Behavioral

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 24 months

    Hemoglobin A1c

Secondary outcomes

  1. Diabetes Knowledge

    Time frame: 24 months

    Diabetes Knowledge

  2. Autonomous Self-Regulation

    Time frame: 24 months

    Autonomous Self-Regulation

  3. Perceived Competence

    Time frame: 24 months

    Perceived Competence

  4. Medication Adherence

    Time frame: 24 months

    Medication Adherence

  5. Body mass index

    Time frame: 24 months

    Body mass index

  6. Diabetes Self-Care Behaviors

    Time frame: 24 months

    Diabetes Self-Care Behaviors

  7. Quality of Life

    Time frame: 24 months

    Quality of Life

  8. Healthcare Utilization

    Time frame: 24 months

    Healthcare Utilization

  9. Systolic Blood Pressure

    Time frame: 24 months

    Systolic Blood Pressure

  10. Diastolic Blood Pressure

    Time frame: 24 months

    Diastolic Blood Pressure

  11. LDL Cholesterol

    Time frame: 24 months

    LDL Cholesterol

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Dec 23, 2011
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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