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Investigators will conduct a hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) to evaluate the effectiveness of iMatter2 versus usual care on reduction in HbA1c at 12-months (primary outcome) among patients with Type 2 diabetes (T2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iMatter2 | Experimental | All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2. |
|
| Usual Care (UC) | No Intervention | All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool | Other | Once the program begins, the AI chatbot sends daily text messages that include the PRO questions; a link to a library of educational resources tailored to their responses and personalized motivational messages with support. Participants will also be sent links to the interactive web-based dashboard that visualizes their daily PRO and HbA1c data. PCPs will be able to view reports of patients' PRO and A1c data through the EHR interface, which can be reviewed during visits with the patient or asynchronously to track patient PROs between visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1C (HbA1c) | HbA1c will be extracted from lab data available within the EHR | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Eligible for Participation in Trial who Enroll | Up to Month 14 | |
| Percentage of PCP Practices Eligible for Participation in Trial that Enroll | Up to Month 14 | |
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Inclusion Criteria:
PCP Group:
Patient Group:
Exclusion Criteria:
Patient Group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Priscilla D'antico | Contact | 732-501-9057 | Priscilla.D'antico@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Antoinette Schoenthaler | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
IPD collected in this study will be available only to:
• The research team, including the Principal Investigator, study coordinators, and personnel responsible for the support or oversight of the study
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D000071066 | Patient Reported Outcome Measures |
| C448039 | prolyl-proline |
| D004864 | Equipment and Supplies |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D019538 | Health Care Surveys |
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|
| Percentage of Providers who View PRO Reports |
| Up to Month 14 |
| Percentage of Patients who Respond to PRO Text Messages | Up to Month 14 |
| Percentage of Patients who View PRO Interactive Dashboard | Up to Month 14 |
| Mean Number of EHR Reports Viewed by Providers | Up to Month 14 |
| Total Number of EHR Reports Viewed by Providers | Up to Month 14 |
| Percentage of PRO Messages Responded To by Patients | Up to Month 14 |
| Mean Number of PRO Messages Responded To by Patients | Up to Month 14 |
| Total Number of PRO Messages Responded To by Patients | Up to Month 14 |
| Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard | Up to Month 14 |
| Total Number of Reports Viewed by Patients via PRO Interactive Dashboard | Up to Month 14 |
| D004700 | Endocrine System Diseases |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |