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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are:
Researchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk-Informed Shared Decision-Making Engagement Strategy | Active Comparator | Participants will have one visit with a healthcare team member to talk about the participant's risk of diabetes and how to lower it. |
|
| Low Touch Messaging Strategy | Active Comparator | Participants receive a simple message in the patient portal describing the participant's level of risk of diabetes and tips on how to lower the risk |
|
| Usual Care | No Intervention | Participants will continue with usual care at the clinic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk Informed Shared Decision-Making Strategy (RISE) | Other | Single visit with health care team member to discuss diabetes risk and choosing next steps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of a DPP referral or new metformin prescription | Prediabetes treatment uptake - Presence of a DPP referral or new metformin prescription based on electronic health record data | From randomization to 3 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients enrolled in the DPP | DPP enrollment- Proportion of patients enrolled in the DPP - | Referral to 6 months after DPP referral |
| Proportion of patients who complete ≥ 9 months of the DPP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Study Coordinator | Contact | 410-614-4396 | preventdiabetes@jh.edu | |
| Eva Tseng, MD, MPH | Contact | etseng3@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eva Tseng, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Community Physicians Frederick | Frederick | Maryland | 21702 | United States |
Only de-identified IPD used in the results publication will be shared
Beginning 1 year after publication with no end date
All de-identified datasets that can be shared will be deposited in figshare, an open access ADA-approved repository.
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| Low Touch Messaging Strategy (LTM) | Other | Single message delivered via patient portal system describing diabetes risk and tips to lower risk |
|
DPP completion- Proportion of patients who complete ≥ 9 months of the DPP
| From enrollment to 12 months of follow-up |
| Weight change (kg) | Change in body weight | From enrollment to 12 months |
| Metformin adherence | Proportion of participants with a new metformin prescription who have a proportion-of-days covered (PDC) value of ≥0.80 (calculated as the sum of days' supply of metformin divided by the number of days between the first fill and end of follow-up period). | From enrollment to 12 months |
| Hemoglobin A1c change | Absolute change in hemoglobin A1c | From enrollment to 12 months |
| Patient Activation Measure | Patient Activation Measure (PAM) scored as Level 1(disengaged) - 4 (proactive) | From enrollment to 3 months and from enrollment to 12 months |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006943 | Hyperglycemia |
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