An interventional study of Primary Care-Occupational Therapy and Enhanced Usual Care in Type 2 Diabetes and Mild Cognitive Impairment, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-08-10.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Prevention
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 101 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Usual care enhanced with education and controls for attention
Behavioral: Enhanced Usual Care
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).
Usual care enhanced with education and attention
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
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
| Milestone | Primary Care-Occupational Therapy | Enhanced Usual Care |
|---|---|---|
| Started | 50 | 51 |
| Completed | 41 | 46 |
| Not completed | 9 | 5 |
| Withdrew: Withdrawal by subject | 7 | 2 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 3 |
Percent of participants who had a reduction (improvement) of at least .5% in hemoglobin A1c from baseline to 6 months
| Participants | Primary Care-Occupational Therapy | Enhanced Usual Care |
|---|---|---|
| Percent of Participants With Improvement in Hemoglobin A1c by 0.5%" | 25 | 22 |
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.
| percentage of doses taken during period | Primary Care-Occupational Therapy | Enhanced Usual Care |
|---|---|---|
| Adherence as Measured By Percentage of Doses Taken as Prescribed | 61 (53 to 69) | 60 (52 to 68) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Care-Occupational Therapy | 2/50 (4%) | 18/50 (36%) | 0/50 (0%) |
| Enhanced Usual Care | 0/51 (0%) | 16/51 (31.4%) | 0/51 (0%) |
| Event | Primary Care-Occupational Therapy | Enhanced Usual Care |
|---|---|---|
| Cardiac eventsCardiac disorders | 8/50 | 4/51 |
| InfectionInfections and infestations | 3/50 | 7/51 |
| COPD, pneumoniaRespiratory, thoracic and mediastinal disorders | 5/50 | 4/51 |
| GIGastrointestinal disorders | 4/50 | 2/51 |
| DehydrationMetabolism and nutrition disorders | 2/50 | 0/51 |
| Stroke/TIAVascular disorders | 2/50 | 1/51 |
| DiabetesEndocrine disorders | 0/50 | 2/51 |
| CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/50 | 2/51 |
| Renal failure/kidney injuryRenal and urinary disorders | 0/50 | 2/51 |
| Facial FractureMusculoskeletal and connective tissue disorders | 1/50 | 0/51 |
A total of 101 participants with MCI were randomized to PC-OT (n = 50) or EUC (n = 51). The average age of participants was 68.4 (6.4) years (range = 60-85 years), and 62% were women. All were African American.
| Age, Continuous(years) | Primary Care-Occupational Therapy | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 68.2 ± 6.1 | 68.7 ± 6.7 | 68.4 ± 6.4 |
| Sex: Female, Male(Participants) | Primary Care-Occupational Therapy | Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 31 | 32 | 63 |
| Male | 19 | 19 | 38 |
| Race (NIH/OMB)(Participants) | Primary Care-Occupational Therapy | Enhanced Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 50 | 51 | 101 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Primary Care-Occupational Therapy | Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 50 | 51 | 101 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Thomas Jefferson University