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Improving Medication Adherence in Older African Americans With Diabetes

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ClinicalTrials.gov Identifier: NCT02174562
Recruitment Status : Completed
First Posted : June 25, 2014
Results First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mild Cognitive Impairment Behavioral: Primary Care-Occupational Therapy Behavioral: Enhanced Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Medication Adherence in Older African Americans With Diabetes
Actual Study Start Date : July 2014
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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).
Behavioral: 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).

Placebo Comparator: Enhanced Usual Care
Usual care enhanced with education and controls for attention
Behavioral: Enhanced Usual Care
Usual care enhanced with education and attention




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174562


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Johns Hopkins University
Investigators
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Principal Investigator: Barry W Rovner, MD Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02174562    
Other Study ID Numbers: R01DK102609-01 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2014    Key Record Dates
Results First Posted: June 16, 2020
Last Update Posted: June 16, 2020
Last Verified: June 2020
Keywords provided by Thomas Jefferson University:
Type 2 diabetes
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Cognitive Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders