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Improving Medication Adherence in Older African Americans With Diabetes

Improving Medication Adherence in Older African Americans With Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02174562
Enrollment
101
Registered
2014-06-25
Start date
2014-07-31
Completion date
2019-12-31
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Type 2 Diabetes

Keywords

Type 2 diabetes, Mild Cognitive Impairment

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.

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.

Interventions

BEHAVIORALPrimary 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).

BEHAVIORALEnhanced Usual Care

Usual care enhanced with education and attention

Sponsors

Johns Hopkins University
CollaboratorOTHER
Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percent of Participants With Improvement in Hemoglobin A1c by 0.5%6 monthsPercent of participants who had a reduction (improvement) of at least .5% in hemoglobin A1c from baseline to 6 months

Secondary

MeasureTime frameDescription
Adherence as Measured By Percentage of Doses Taken as Prescribed4-6 monthsThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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). 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).
50
Enhanced Usual Care
Usual care enhanced with education and controls for attention Enhanced Usual Care: Usual care enhanced with education and attention
51
Total101

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath20
Overall StudyLost to Follow-up03
Overall StudyWithdrawal by Subject72

Baseline characteristics

CharacteristicPrimary Care-Occupational TherapyTotalEnhanced Usual Care
Age, Continuous68.2 years
STANDARD_DEVIATION 6.1
68.4 years
STANDARD_DEVIATION 6.4
68.7 years
STANDARD_DEVIATION 6.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
50 Participants101 Participants51 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
50 participants101 participants51 participants
Sex: Female, Male
Female
31 Participants63 Participants32 Participants
Sex: Female, Male
Male
19 Participants38 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 500 / 51
other
Total, other adverse events
0 / 500 / 51
serious
Total, serious adverse events
18 / 5016 / 51

Outcome results

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Primary Care-Occupational TherapyPercent of Participants With Improvement in Hemoglobin A1c by 0.5%25 Participants
Enhanced Usual CarePercent of Participants With Improvement in Hemoglobin A1c by 0.5%22 Participants
Comparison: Null hypothesis is that the Relative Risk of reduction of HbA1C \>=0.5 for PCOT vs EUC is 1.p-value: 0.3195% CI: [0.84, 1.75]Poisson regression with robust SEs
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.

Time frame: 4-6 months

ArmMeasureValue (LEAST_SQUARES_MEAN)
Primary Care-Occupational TherapyAdherence as Measured By Percentage of Doses Taken as Prescribed61 percentage of doses taken during period
Enhanced Usual CareAdherence as Measured By Percentage of Doses Taken as Prescribed60 percentage of doses taken during period
Comparison: Mixed effects linear regression was used to model the percentage of doses taken each month. Fixed effects were period (1-3 months, 4-6 months, 7-9 months, 10-12 months), randomization group, randomization by period interaction, stratification group, age, and run-in percentage doses taken. The outcome was transformed using the arcsin-square root transformation prior to analysis. A first-order autoregressive correlation structure was assumed.p-value: 0.87Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026