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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG057291-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to develop and test a care quality improvement intervention featuring use of consensus decisional guidance for the medical management of diabetes (DM) in patients with Alzheimer's disease and related dementia (ADRD) in primary care, provider (PCP) workflow enhancements supported by a panel manager(PM) for workflow support, electronic health record (EHR) decision support and feedback, and PCP collaborative learning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (INT) | Experimental | (10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) |
|
| Control (CON) | Placebo Comparator | During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EQUIPED-ADRD Intervention | Behavioral | (10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Reach Consensus Target HBA1c | Percentage of patients with normal HbA1c (>=7 and <=8.5) at the end of the trial after completing the 24-month Follow-up and who had reported values in their electronic health record within 6 months of study completion. | Up to Month 24 |
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Inclusion Criteria:
Caregiver:
Exclusion Criteria:
Patient:
Caregiver:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Chodosh, MD, MSHS, FACP | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41297852 | Derived | Adeyemi O, Christina W, Arcila-Mesa M, Dickson VV, Ferris R, Tarpey T, Fletcher J, Blaum C, Chodosh J. Enhanced quality in primary care for elders with diabetes and dementia: Protocol for a multisite randomized controlled trial. Contemp Clin Trials. 2026 Jan;160:108165. doi: 10.1016/j.cct.2025.108165. Epub 2025 Nov 24. |
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All of the individual participant data collected during the trial, after deidentification and publication.
Beginning 9 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (INT) | (10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) EQUIPED-ADRD Intervention: (10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) |
| FG001 | Control (CON) | During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (INT) | (10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) EQUIPED-ADRD Intervention: (10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Patients Who Reach Consensus Target HBA1c | Percentage of patients with normal HbA1c (>=7 and <=8.5) at the end of the trial after completing the 24-month Follow-up and who had reported values in their electronic health record within 6 months of study completion. | Posted | Mean | 95% Confidence Interval | percentage of participants | Up to Month 24 |
|
24 Months
Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
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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 | Intervention (INT) | (10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) EQUIPED-ADRD Intervention: (10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mauricio Arcila-Mesa | NYU Langone Health | 646-501-4660 | Mauricio.arcila-mesa@nyulangone.org |
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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 20, 2021 | Oct 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Control (CON) | Behavioral | Will use current guidelines for primary care treatment with Diabetes and Dementia |
|
| No longer receiving care at NYU Langone Health |
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| Lost to Follow-up |
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| Discontinued after study closure |
|
| BG001 | Control (CON) | During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control (CON) | During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia |
|
|
| 33 |
| 191 |
| 69 |
| 191 |
| 0 |
| 191 |
| EG001 | Control (CON) | During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia | 32 | 164 | 65 | 164 | 0 | 164 |
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arterial injury | Vascular disorders | Systematic Assessment |
|
| Arterial thromboembolism | Vascular disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiac troponin increased | Investigations | Systematic Assessment |
|
| Chest pain -cardiac | Cardiac disorders | Systematic Assessment |
|
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Colonic hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Colonic Obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Death NOS | General disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Edema limbs | General disorders | Systematic Assessment |
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| Enterocolitis infectious. | Gastrointestinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Eye infection | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gallbladder pain | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypothermia | General disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Injury, poisoning and procedural complications- other | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | Systematic Assessment |
|
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Liver Failure | Hepatobiliary disorders | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Lung Infection | Infections and infestations | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Skin Infection | Infections and infestations | Systematic Assessment |
|
| Skin Ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Social circumstances | General disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Vision decreased | Eye disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |