Type 2 Diabetes
Conditions
Brief summary
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).
Interventions
OTHERMobile Health (mHealth) Patient-Reported Outcome (PRO) tool
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PCP Group: * Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and * Provide care to at least five patients with a diagnosis of T2D Patient Group: * Have a diagnosis of T2D for ≥6 months; * Have uncontrolled T2D defined as HbA1c \>7% documented in the EHR on at least two visits in the past year; * Fluency in English or Spanish; * Be willing to send/receive text messages; and * Be \> 18 years of age.
Exclusion criteria
Patient Group: * Refuse or are unable to provide informed consent; * Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, renal transplantation, or other ESRD-related services documented in the EHR; * Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR); * Are pregnant or planning to become pregnant within 12 months; * Currently participate in another T2D study; or * Plan to discontinue care at the clinic within the next 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1C (HbA1c) | Baseline, Month 12 | HbA1c will be extracted from lab data available within the EHR |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDevin Mann
NYU Langone Health
Outcome results
None listed