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N/A N=101 Randomized Single-blind Prevention

Improving Medication Adherence in Older African Americans With Diabetes

Type 2 Diabetes · Mild Cognitive Impairment

Enrolled (actual)
101
Serious AEs
33.7%
Results posted
Jun 2020
Primary outcome: Primary: Percent of Participants With Improvement in Hemoglobin A1c by 0.5%" — 25; 22 Participants — p=0.31

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Primary Care-Occupational Therapy (Behavioral); Enhanced Usual Care (Behavioral)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
Thomas Jefferson University
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent of Participants With Improvement in Hemoglobin A1c by 0.5%"
25; 22 0.31
SECONDARY
Adherence as Measured By Percentage of Doses Taken as Prescribed
61; 60 0.87

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02174562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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