Health Promoters and Pharmacists in Diabetes Team Management

This study is currently recruiting participants.
Verified December 2013 by University of Illinois at Chicago
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ben Gerber, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01498159
First received: December 15, 2011
Last updated: December 16, 2013
Last verified: December 2013

December 15, 2011
December 16, 2013
December 2011
December 2016   (final data collection date for primary outcome measure)
  • Hemoglobin A1c [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01498159 on ClinicalTrials.gov Archive Site
  • Diabetes Knowledge [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Autonomous Self-Regulation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Perceived Competence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Medication Adherence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Diabetes Self-Care Behaviors [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Healthcare Utilization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Health Promoters and Pharmacists in Diabetes Team Management
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.

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 neighbors 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Health Services Research
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
  • Experimental: Pharmacist + Health Promoter
    Interventions:
    • 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
    Interventions:
    • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2017
December 2016   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Lauren Rapacki, MS 312-413-1642 lrapacki@uic.edu
United States
 
NCT01498159
2011-0099, R01DK091347
No
Ben Gerber, University of Illinois at Chicago
University of Illinois at Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Ben S Gerber, MD, MPH University of Illinois at Chicago
Principal Investigator: Lisa K Sharp, PhD University of Illinois at Chicago
University of Illinois at Chicago
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP