AIManage Using an AI-driven CDS and Chatbot

April 16, 2026 updated by: NYU Langone Health

AIManage: Using an AI-driven CDS and Chatbot for the Management of Patients on Incretin Mimetic Medications

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).

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Provider Exclusion Criteria (Phase 1) • Refuse to participate

Patient Exclusion Criteria (Phase 1)

• Refuse or are unable to provide informed consent;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Providers (Phase 1)
Providers prescribing IMM for at least 5 adult patients in primary care and obesity medicine clinics.
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.
Experimental: Patients (Phase 1)
Adult patients prescribed an IMM in the past 6 months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients who Complete Qualitative Measure - Perceived Usefulness
Time Frame: Day 1 (60 minutes)
In Phase 1, qualitative data regarding perceived usefulness will be collected.
Day 1 (60 minutes)
Percentage of Patients who Complete Qualitative Measure - Perceived Usability
Time Frame: Day 1 (60 minutes)
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
Time Frame: Day 1 (60 minutes)
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
Time Frame: Day 1 (60 minutes)
In Phase 1, qualitative data regarding perceived value will be collected.
Day 1 (60 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeth Stevens, PhD, MPH, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

March 30, 2029

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

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