NCT01498159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

4.3 years

First QC Date

December 15, 2011

Last Update Submit

April 30, 2018

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusPharmacistsCommunity Health Aides

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Hemoglobin A1c

    24 months

Secondary Outcomes (11)

  • Diabetes Knowledge

    24 months

  • Autonomous Self-Regulation

    24 months

  • Perceived Competence

    24 months

  • Medication Adherence

    24 months

  • Body mass index

    24 months

  • +6 more secondary outcomes

Study Arms (2)

Pharmacist + Health Promoter

EXPERIMENTAL

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 managementBehavioral: Pharmacist-patient encountersBehavioral: Pharmacist medication intensification and adherence supportBehavioral: Pharmacist communication with primary care physiciansBehavioral: Pharmacist documentation in electronic medical recordBehavioral: Health promoter-patient encounters in-person or by phoneBehavioral: Health promoter medication and lifestyle supportBehavioral: Health promoter communication with pharmacists

Pharmacist

ACTIVE COMPARATOR

Participants will receive support from pharmacist.

Behavioral: Pharmacist disease/medication managementBehavioral: Pharmacist-patient encountersBehavioral: Pharmacist medication intensification and adherence supportBehavioral: Pharmacist communication with primary care physiciansBehavioral: Pharmacist documentation in electronic medical record

Interventions

Pharmacist disease/medication managementBEHAVIORAL
PharmacistPharmacist + Health Promoter
Pharmacist-patient encountersBEHAVIORAL
PharmacistPharmacist + Health Promoter
Pharmacist medication intensification and adherence supportBEHAVIORAL
PharmacistPharmacist + Health Promoter
Pharmacist communication with primary care physiciansBEHAVIORAL
PharmacistPharmacist + Health Promoter
Pharmacist documentation in electronic medical recordBEHAVIORAL
PharmacistPharmacist + Health Promoter
Health promoter-patient encounters in-person or by phoneBEHAVIORAL
Pharmacist + Health Promoter
Health promoter medication and lifestyle supportBEHAVIORAL
Pharmacist + Health Promoter
Health promoter communication with pharmacistsBEHAVIORAL
Pharmacist + Health Promoter

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

  • Gerber BS, Cano AI, Caceres ML, Smith DE, Wilken LA, Michaud JB, Ruggiero LA, Sharp LK. A pharmacist and health promoter team to improve medication adherence among Latinos with diabetes. Ann Pharmacother. 2010 Jan;44(1):70-9. doi: 10.1345/aph.1M389. Epub 2009 Dec 22.

    PMID: 20028957BACKGROUND

  • Gerber BS, Rapacki L, Castillo A, Tilton J, Touchette DR, Mihailescu D, Berbaum ML, Sharp LK. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes. BMC Public Health. 2012 Oct 23;12:891. doi: 10.1186/1471-2458-12-891.

    PMID: 23088168BACKGROUND

  • Sharp LK, Tilton JJ, Touchette DR, Xia Y, Mihailescu D, Berbaum ML, Gerber BS. Community Health Workers Supporting Clinical Pharmacists in Diabetes Management: A Randomized Controlled Trial. Pharmacotherapy. 2018 Jan;38(1):58-68. doi: 10.1002/phar.2058. Epub 2017 Nov 30.

    PMID: 29121408RESULT

  • Nabulsi NA, Yan CH, Tilton JJ, Gerber BS, Sharp LK. Clinical pharmacists in diabetes management: What do minority patients with uncontrolled diabetes have to say? J Am Pharm Assoc (2003). 2020 Sep-Oct;60(5):708-715. doi: 10.1016/j.japh.2020.01.024. Epub 2020 Feb 27.

    PMID: 32115392DERIVED

  • Locatelli SM, Sharp LK, Syed ST, Bhansari S, Gerber BS. Measuring Health-related Transportation Barriers in Urban Settings. J Appl Meas. 2017;18(2):178-193.

    PMID: 28961153DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Physicians, Primary CareElectronic Health RecordsPharmacists

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and ServicesMedical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ben S Gerber, MD, MPH

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

  • Lisa K Sharp, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 23, 2011

Study Start

December 1, 2011

Primary Completion

April 1, 2016

Study Completion

January 1, 2018

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations

US(1)