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Enhanced Quality in Primary Care for Elders With Diabetes and Dementia
NA trial testing EQUIPED-ADRD Intervention in Diabetes in 355 participants. Completed in 20 October 2022.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 355 |
| Start date | 3 December 2018 |
| Primary completion | 20 October 2022 |
| Estimated completion | 20 October 2022 |
| Sites | 1 location across United States |
NYU Langone Health — full company profile →
65 and older, any sex, with Diabetes or Dementia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention (INT) | 12 | -1.3 – 25.3 |
| Control (CON) | 18.75 | 4.7 – 32.8 |
Time frame: 24 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention (INT) | Control (CON) |
|---|---|---|---|
| Death NOS | General disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Syncope | Nervous system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Heart Failure | Cardiac disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Lung Infection | Infections and infestations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardiac Arrest | Cardiac disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — |
| Myocardial Infarction | Cardiac disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Agitation | Psychiatric disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Cholecystitis | Gastrointestinal disorders | — | — |
| Delirium | Psychiatric disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
Most-reported serious reactions: Death NOS, Fall, Upper respiratory infection, Syncope, Abdominal pain, Heart Failure, Hyperglycemia, Urinary tract infection.
Data from ClinicalTrials.gov NCT03723707 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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