Trial Outcomes & Findings for Improving Medication Adherence in Older African Americans With Diabetes (NCT NCT02174562)
NCT ID: NCT02174562
Last Updated: 2020-08-10
Results Overview
Percent of participants who had a reduction (improvement) of at least .5% in hemoglobin A1c from baseline to 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
6 months
Results posted on
2020-08-10
Participant Flow
Participant milestones
| Measure |
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).
|
Enhanced Usual Care
Usual care enhanced with education and controls for attention
Enhanced Usual Care: Usual care enhanced with education and attention
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
41
|
46
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
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).
|
Enhanced Usual Care
Usual care enhanced with education and controls for attention
Enhanced Usual Care: Usual care enhanced with education and attention
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Improving Medication Adherence in Older African Americans With Diabetes
Baseline characteristics by cohort
| Measure |
Primary Care-Occupational Therapy
n=50 Participants
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).
|
Enhanced Usual Care
n=51 Participants
Usual care enhanced with education and controls for attention
Enhanced Usual Care: Usual care enhanced with education and attention
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
101 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercent of participants who had a reduction (improvement) of at least .5% in hemoglobin A1c from baseline to 6 months
Outcome measures
| Measure |
Primary Care-Occupational Therapy
n=41 Participants
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).
|
Enhanced Usual Care
n=46 Participants
Usual care enhanced with education and controls for attention
Enhanced Usual Care: Usual care enhanced with education and attention
|
|---|---|---|
|
Percent of Participants With Improvement in Hemoglobin A1c by 0.5%"
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 4-6 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.
Outcome measures
| Measure |
Primary Care-Occupational Therapy
n=45 Participants
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).
|
Enhanced Usual Care
n=44 Participants
Usual care enhanced with education and controls for attention
Enhanced Usual Care: Usual care enhanced with education and attention
|
|---|---|---|
|
Adherence as Measured By Percentage of Doses Taken as Prescribed
|
61 percentage of doses taken during period
Interval 53.0 to 69.0
|
60 percentage of doses taken during period
Interval 52.0 to 68.0
|
Adverse Events
Primary Care-Occupational Therapy
Serious events: 18 serious events
Other events: 0 other events
Deaths: 2 deaths
Enhanced Usual Care
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Care-Occupational Therapy
n=50 participants at risk
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).
|
Enhanced Usual Care
n=51 participants at risk
Usual care enhanced with education and controls for attention
Enhanced Usual Care: Usual care enhanced with education and attention
|
|---|---|---|
|
Infections and infestations
Infection
|
6.0%
3/50 • Number of events 3 • 1 year
|
13.7%
7/51 • Number of events 12 • 1 year
|
|
Cardiac disorders
Cardiac events
|
16.0%
8/50 • Number of events 9 • 1 year
|
7.8%
4/51 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
GI
|
8.0%
4/50 • Number of events 4 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Facial Fracture
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Endocrine disorders
Diabetes
|
0.00%
0/50 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.0%
1/50 • Number of events 1 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hip surgery
|
0.00%
0/50 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50 • Number of events 2 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/50 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COPD, pneumonia
|
10.0%
5/50 • Number of events 5 • 1 year
|
7.8%
4/51 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
Kidney stones
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/51 • 1 year
|
|
Renal and urinary disorders
Renal failure/kidney injury
|
0.00%
0/50 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
|
Vascular disorders
Stroke/TIA
|
4.0%
2/50 • Number of events 2 • 1 year
|
2.0%
1/51 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place