Clinical trial NCT05884775: Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
Official title: iMatter2: An Artificial Intelligence (AI)-Driven Approach to Supercharge a Novel Digital Patient-reported Outcomes Tool for Diabetes Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Hemoglobin A1C (HbA1c)
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percentage of Patients Eligible for Participation in Trial who Enroll
timeFrame: Up to Month 14
measure: Percentage of PCP Practices Eligible for Participation in Trial that Enroll
timeFrame: Up to Month 14
measure: Percentage of Providers who View PRO Reports
timeFrame: Up to Month 14
measure: Percentage of Patients who Respond to PRO Text Messages
timeFrame: Up to Month 14
measure: Percentage of Patients who View PRO Interactive Dashboard
timeFrame: Up to Month 14
measure: Mean Number of EHR Reports Viewed by Providers
timeFrame: Up to Month 14
measure: Total Number of EHR Reports Viewed by Providers
timeFrame: Up to Month 14
measure: Percentage of PRO Messages Responded To by Patients
timeFrame: Up to Month 14
measure: Mean Number of PRO Messages Responded To by Patients
timeFrame: Up to Month 14
measure: Total Number of PRO Messages Responded To by Patients
timeFrame: Up to Month 14
measure: Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard
timeFrame: Up to Month 14
measure: Total Number of Reports Viewed by Patients via PRO Interactive Dashboard
timeFrame: Up to Month 14
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Antoinette Schoenthaler
role: PRINCIPAL_INVESTIGATOR
References: