Improving Medication Adherence in Older African Americans With Diabetes

NCT02174562 | Completed Results

• 1 other identifier: R01DK102609-01
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Mild Cognitive Impairment

Keywords

Type 2 diabetes; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adherence as Measured By Percentage of Doses Taken as Prescribed

  4-6 months

Study Arms (2)

Primary Care-Occupational Therapy

EXPERIMENTAL

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).

Behavioral: Primary Care-Occupational Therapy

Enhanced Usual Care

PLACEBO COMPARATOR

Usual care enhanced with education and controls for attention

Behavioral: Enhanced Usual Care

Interventions

Primary Care-Occupational Therapy BEHAVIORAL

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).

Primary Care-Occupational Therapy

Enhanced Usual Care BEHAVIORAL

Usual care enhanced with education and attention

Enhanced Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• 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.

  PMID: 33752964 DERIVED

• 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.

  PMID: 32043561 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Barry Rovner, MD
• Organization: Thomas Jefferson University

Barry.Rovner@Jefferson.edu

215-503-1243

Study Officials

• Barry W Rovner, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 25, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 10, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-08

Locations

US (1)