Improving Medication Adherence in Older African Americans With Diabetes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cognitive Studies, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 2/23/2019 |
| Start Date: | July 2014 |
| End Date: | June 2019 |
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.
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.
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.
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.
Inclusion Criteria:
1. Age 65 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, 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. Treatment with insulin or other injectable.
3. DSM-V psychiatric disorder other than depressive disorders.
4. End-stage renal disease requiring dialysis.
5. Hearing/Vision (i.e., severe diabetic retinopathy) or motor (e.g., peripheral
neuropathy) impairment that precludes research participation.
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