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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Care-Occupational Therapy | Experimental | 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 | Placebo Comparator | Usual care enhanced with education and controls for attention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Care-Occupational Therapy | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry W Rovner, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33752964 | Derived | Rovner BW, Casten RJ. Emergency department visits in African Americans with mild cognitive impairment and diabetes. J Diabetes Complications. 2021 May;35(5):107905. doi: 10.1016/j.jdiacomp.2021.107905. Epub 2021 Mar 16. | |
| 32043561 | Derived | Rovner BW, Casten RJ, Piersol CV, White N, Kelley M, Leiby BE. Improving Glycemic Control in African Americans With Diabetes and Mild Cognitive Impairment. J Am Geriatr Soc. 2020 May;68(5):1015-1022. doi: 10.1111/jgs.16339. Epub 2020 Feb 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Enhanced Usual Care | Usual care enhanced with education and controls for attention Enhanced Usual Care: Usual care enhanced with education and attention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 6 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barry Rovner, MD | Thomas Jefferson University | 215-503-1243 | Barry.Rovner@Jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2015 | Jul 14, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Enhanced Usual Care | Behavioral | Usual care enhanced with education and attention |
|
| Lost to Follow-up |
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| BG001 | Enhanced Usual Care | Usual care enhanced with education and controls for attention Enhanced Usual Care: Usual care enhanced with education and attention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Enhanced Usual Care | Usual care enhanced with education and controls for attention Enhanced Usual Care: Usual care enhanced with education and attention |
|
|
|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of doses taken during period | 4-6 months |
|
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|
|
| 2 |
| 50 |
| 18 |
| 50 |
| 0 |
| 50 |
| EG001 | Enhanced Usual Care | Usual care enhanced with education and controls for attention Enhanced Usual Care: Usual care enhanced with education and attention | 0 | 51 | 16 | 51 | 0 | 51 |
| Cardiac events | Cardiac disorders | Systematic Assessment |
|
| GI | Gastrointestinal disorders | Systematic Assessment |
|
| Facial Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Diabetes | Endocrine disorders | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hip surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Polyarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| COPD, pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Kidney stones | Renal and urinary disorders | Systematic Assessment |
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| Renal failure/kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Stroke/TIA | Vascular disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |