- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01498159
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
Status
Completed
Conditions
Intervention / Treatment
- 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
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
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-
Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois Medical Center
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-
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)
Arms and Interventions
Participant Group / 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.
|
|
Active Comparator: Pharmacist
Participants will receive support from pharmacist.
|
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.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
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
Additional Relevant MeSH Terms
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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