Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Conditions
Keywords
shared decision-making, diabetes risk, diabetes prevention
Brief summary
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: * Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes? * Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes? 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: * Complete surveys at the beginning of the study and up to 2 additional surveys * If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.
Interventions
OTHERRisk Informed Shared Decision-Making Strategy (RISE)
Single visit with health care team member to discuss diabetes risk and choosing next steps
OTHERLow Touch Messaging Strategy (LTM)
Single message delivered via patient portal system describing diabetes risk and tips to lower risk
Sponsors
Johns Hopkins University
American Diabetes Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg/dL) in prior 12 months * active patient portal account (MyChart) * patient receiving primary care at Johns Hopkins Community Physicians in Frederick * have overweight or obesity (BMI ≥ 25 kg/m2)
Exclusion criteria
* have diabetes (HbA1c \> 6.4% in prior 6 months or on diabetes registry) * have dementia * previously participated in the Diabetes Prevention Program (DPP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of a DPP referral or new metformin prescription | From randomization to 3 months after randomization | Prediabetes treatment uptake - Presence of a DPP referral or new metformin prescription based on electronic health record data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c change | From enrollment to 12 months | Absolute change in hemoglobin A1c |
| Patient Activation Measure | From enrollment to 3 months and from enrollment to 12 months | Patient Activation Measure (PAM) scored as Level 1(disengaged) - 4 (proactive) |
| Metformin adherence | From enrollment to 12 months | 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). |
| Weight change (kg) | From enrollment to 12 months | Change in body weight |
| Proportion of patients enrolled in the DPP | Referral to 6 months after DPP referral | DPP enrollment- Proportion of patients enrolled in the DPP - |
| Proportion of patients who complete ≥ 9 months of the DPP | From enrollment to 12 months of follow-up | DPP completion- Proportion of patients who complete ≥ 9 months of the DPP |
Countries
United States
Contacts
CONTACTResearch Study Coordinator
CONTACTEva Tseng, MD, MPH
PRINCIPAL_INVESTIGATOREva Tseng, MD, MPH
Johns Hopkins University
Outcome results
None listed