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Health Promoters and Pharmacists in Diabetes Team Management

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ClinicalTrials.gov Identifier: NCT01498159
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ben Gerber, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: 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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Health Promoters and Pharmacists in Diabetes Team Management
Study Start Date : December 2011
Actual Primary Completion Date : April 2016
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: Pharmacist + Health Promoter
Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.
Behavioral: 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
Active Comparator: Pharmacist
Participants will receive support from pharmacist.
Behavioral: 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



Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 24 months ]
    Hemoglobin A1c


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498159


Locations
United States, Illinois
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ben S Gerber, MD, MPH University of Illinois at Chicago
Principal Investigator: Lisa K Sharp, PhD University of Illinois at Chicago

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ben Gerber, Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01498159     History of Changes
Other Study ID Numbers: 2011-0099
R01DK091347 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018

Keywords provided by Ben Gerber, University of Illinois at Chicago:
Diabetes Mellitus
Pharmacists
Community Health Aides

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases