Type 2 Diabetes Clinical Trial
Official title:
Improving Medication Adherence in Older African Americans With Diabetes
NCT number | NCT02174562 |
Other study ID # | R01DK102609-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | December 2019 |
Verified date | August 2020 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 60 years and older. 2. Self-identified as African American, black, black American, or black/Caribbean. 3. Type II DM (i.e., physician diagnosis and medication treatment). 4. HbA1c level = 7.5%. 5. MCI, based on National Institute on Aging/Alzheimer's Association (NIA/AA) criteria. 6. = 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: 1. Dementia, based on National Institute on Aging/Alzheimer's Association criteria. 2. DSM-V psychiatric disorder other than depressive disorders. 3. End-stage renal disease requiring dialysis. 4. Hearing/Vision (i.e., severe diabetic retinopathy) or motor (e.g., peripheral neuropathy) impairment that precludes research participation. |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of Participants With Improvement in Hemoglobin A1c by 0.5%" | Percent of participants who had a reduction (improvement) of at least .5% in hemoglobin A1c from baseline to 6 months | 6 months | |
Secondary | Adherence as Measured By Percentage of Doses Taken as Prescribed | 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 |
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