Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
NCT ID: NCT05884775
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
353 participants
INTERVENTIONAL
2025-08-01
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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iMatter2
All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2.
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.
Usual Care (UC)
All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Antoinette Schoenthaler
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-00608
Identifier Type: -
Identifier Source: org_study_id
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