- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02174562
Improving Medication Adherence in Older African Americans With Diabetes
August 6, 2020 updated by: Thomas Jefferson University
This research aims to help older African Americans with diabetes and mild memory problems improve how they take their medications and control their diabetes.
This may preserve their independence and health, prevent cognitive and functional decline, and reduce health care costs.
As the population ages and becomes more racially diverse, finding ways to achieve these outcomes has great public health importance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The prevalence of type 2 diabetes (DM) in older persons is increasing rapidly.
DM increases the risk for Mild Cognitive Impairment (MCI), which is a transition state between normal cognition and dementia that is often characterized by memory and executive function deficits.
These deficits reduce adherence to DM medications, which worsens glycemic control and increases the risk for adverse DM-related health outcomes.
Improving medication adherence may prevent these outcomes and reduce health care costs.
This is important to all older persons with DM but particularly to older African Americans (AAs).
They have twice the rate of DM, worse cognitive function, lower medication adherence, and worse glycemic control than whites.
One million older AAs now have DM and their number will double by 2030.
Because 30% also have MCI, low medication adherence is an important problem for them.
This necessitates culturally relevant interventions that compensate for their cognitive deficits and improves their medication adherence and glycemic control.
We propose a randomized controlled clinical trial to test the efficacy of a collaborative Primary Care-Occupational Therapy (PC-OT) intervention to lower hemoglobin A1c (HbA1c) levels in older AAs with DM, MCI, HbA1c ≥ 7.5%, and ≤ 80% adherence to an oral hypoglycemic medication.
PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).
We will recruit 100 participants from primary care clinics and randomize them to PC-OT or Enhanced Usual Care (EUC).
EUC is usual medical care plus low intensity DM education delivered by community health workers.
Participants in both PC-OT and EUC will have 6 initial in-home treatment sessions over 3 months, and then 3 booster sessions during this 12 month study.
The primary outcome is a reduction in HbA1c of 0.5%, which reduces the risk of adverse medical events.
The primary efficacy analysis compares the proportion of participants in PC-OT and EUC who achieve this outcome at month 6 (short term effect) and at month 12 (maintenance effect).
We will measure medication adherence using an electronic Medication Event Monitoring System, prescription refills, and self-reports.
A secondary aim determines if improving medication adherence mediates PC-OT's impact on HbA1c levels.
We will also evaluate PC-OT's effect on other DSM practices; ER visits and hospitalizations; cognition; function; mood; and quality of life; and PC-OT's costs and net financial benefits.
This is the first study to determine if PCPs, collaborating with OTs (who are experts in developing strategies to compensate for cognitive/physical deficits), can improve medication adherence and glycemic control, and prevent cognitive and functional decline in older persons with DM and MCI.
If PC-OT is effective in a high risk population of older AAs, its benefits may extend to all older persons with DM and have enormous public health significance.
Study Type
Interventional
Enrollment (Actual)
101
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
-
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
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 60 years and older.
- Self-identified as African American, black, black American, or black/Caribbean.
- Type II DM (i.e., physician diagnosis and medication treatment).
- HbA1c level ≥ 7.5%.
- MCI, based on National Institute on Aging/Alzheimer's Association (NIA/AA) criteria.
- ≤ 80% adherence to an oral hypoglycemic medication or insuling, as documented during a run-in phase using a Medication Event Monitoring System (MEMS).
Exclusion Criteria:
- Dementia, based on National Institute on Aging/Alzheimer's Association criteria.
- DSM-V psychiatric disorder other than depressive disorders.
- End-stage renal disease requiring dialysis.
- Hearing/Vision (i.e., severe diabetic retinopathy) or motor (e.g., peripheral neuropathy) impairment that precludes research participation.
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Primary Care-Occupational Therapy
PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).
|
PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).
|
PLACEBO_COMPARATOR: Enhanced Usual Care
Usual care enhanced with education and controls for attention
|
Usual care enhanced with education and attention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Participants With Improvement in Hemoglobin A1c by 0.5%"
Time Frame: 6 months
|
Percent of participants who had a reduction (improvement) of at least .5% in hemoglobin A1c from baseline to 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence as Measured By Percentage of Doses Taken as Prescribed
Time Frame: 4-6 months
|
This was assessed objectively using a Medication Event Monitoring System (MEMS) bottle.
The MEMS measured daily bottle openings continuously to assess adherence to insulin or an oral hypoglycemic agent.
The adherence rate is the percent of doses that were taken as prescribed.
|
4-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Barry W Rovner, MD, Thomas Jefferson University
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
- Rovner BW, Casten RJ. Emergency department visits in African Americans with mild cognitive impairment and diabetes. J Diabetes Complications. 2021 May;35(5):107905. doi: 10.1016/j.jdiacomp.2021.107905. Epub 2021 Mar 16.
- Rovner BW, Casten RJ, Piersol CV, White N, Kelley M, Leiby BE. Improving Glycemic Control in African Americans With Diabetes and Mild Cognitive Impairment. J Am Geriatr Soc. 2020 May;68(5):1015-1022. doi: 10.1111/jgs.16339. Epub 2020 Feb 11.
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 (ACTUAL)
July 1, 2014
Primary Completion (ACTUAL)
December 1, 2019
Study Completion (ACTUAL)
December 1, 2019
Study Registration Dates
First Submitted
June 20, 2014
First Submitted That Met QC Criteria
June 23, 2014
First Posted (ESTIMATE)
June 25, 2014
Study Record Updates
Last Update Posted (ACTUAL)
August 10, 2020
Last Update Submitted That Met QC Criteria
August 6, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK102609-01 (NIH)
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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