AIManage Using an AI-driven CDS and Chatbot
AIManage: Using an AI-driven CDS and Chatbot for the Management of Patients on Incretin Mimetic Medications
2 other identifiers
interventional
16
1 country
1
Brief Summary
The objective of this project is to define and test the GenAI-powered Clinical Decision Support (CDS) tool, AIManage, providing a broad range of incretin mimetic medication management services to optimize dose titrations. The study will take place across primary care and obesity medicine clinics at NYUH. The study is currently conducting formative data collection for tool refinement (Phase 1). Once completed, a cluster randomized controlled trial of the AIManage tool will be undertaken (Phase 2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Jun 2026
Typical duration for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2026
CompletedFirst Posted
Study publicly available on registry
April 22, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
Study Completion
Last participant's last visit for all outcomes
March 30, 2029
April 22, 2026
April 1, 2026
1.8 years
April 10, 2026
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Patients who Complete Qualitative Measure - Perceived Usefulness
In Phase 1, qualitative data regarding perceived usefulness will be collected.
Day 1 (60 minutes)
Percentage of Patients who Complete Qualitative Measure - Perceived Usability
In Phase 1, qualitative data regarding perceived usability will be collected.
Day 1 (60 minutes)
Percentage of Patients who Complete Qualitative Measure - Perceived Use Challenges
In Phase 1, qualitative data regarding perceived use challenges will be collected.
Day 1 (60 minutes)
Percentage of Patients who Complete Qualitative Measure - Perceived Value
In Phase 1, qualitative data regarding perceived value will be collected.
Day 1 (60 minutes)
Study Arms (2)
Providers (Phase 1)
EXPERIMENTALProviders prescribing IMM for at least 5 adult patients in primary care and obesity medicine clinics.
Patients (Phase 1)
EXPERIMENTALAdult patients prescribed an IMM in the past 6 months.
Interventions
GenAI-powered CDS tool that provides a range of IMM management services, such as personalized guidance for patients on side effects management and clinical advisement to optimize dose titrations.
Eligibility Criteria
You may qualify if:
- Provider Eligibility Criteria (Phase 1)
- Primary or bariatric care provider (MD/DO, NP) practicing at the participating NYULH clinics,
- Provide care to at least 5 patients prescribed an IMM.
- Patient Eligibility Criteria (Phase 1)
- (Phase 1) Currently taking an IMM or have taken an IMM in the past 6 months;
- Fluency in English or Spanish;
- Be willing to send/receive text messages; and
- Be \> 18 years of age.
You may not qualify if:
- Refuse or are unable to provide informed consent;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Stevens, PhD, MPH
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2026
First Posted
April 22, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
March 30, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Elizabeth.Stevens@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Elizabeth.Stevens@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.