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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05884775
Other study ID # 23-00608
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 15, 2025
Est. completion date October 1, 2028

Study information

Verified date February 2024
Source NYU Langone Health
Contact Antoinette Schoenthaler
Phone 6465013434
Email Antoinette.schoenthaler@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 353
Est. completion date October 1, 2028
Est. primary completion date February 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 vi its 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mobile 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 home A1c data through the EHR interface, which can be reviewed during visits with the patient or asynchronously to track patient PROs between visits.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hemoglobin A1C (HbA1c) HbA1c will be extracted from home A1c kits. Baseline, Month 12
Secondary Percentage of Patients Eligible for Participation in Trial who Enroll Up to Month 12
Secondary Percentage of PCP Practices Eligible for Participation in Trial that Enroll Up to Month 12
Secondary Percentage of Providers who View PRO Reports Up to Month 12
Secondary Percentage of Patients who Respond to PRO Text Messages Up to Month 12
Secondary Percentage of Patients who View PRO Interactive Dashboard Up to Month 12
Secondary Mean Number of EHR Reports Viewed by Providers Up to Month 12
Secondary Total Number of EHR Reports Viewed by Providers Up to Month 12
Secondary Percentage of PRO Messages Responded To by Patients Up to Month 12
Secondary Mean Number of PRO Messages Responded To by Patients Up to Month 12
Secondary Total Number of PRO Messages Responded To by Patients Up to Month 12
Secondary Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard Up to Month 12
Secondary Total Number of Reports Viewed by Patients via PRO Interactive Dashboard Up to Month 12
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