Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Study Overview
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Brief Summary
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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).

Official Title
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iMatter2: An Artificial Intelligence (AI)-Driven Approach to Supercharge a Novel Digital Patient-reported Outcomes Tool for Diabetes Management

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iMatter2<br>All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2. | Other: Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool<br>* 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.<br>* Other names: iMatter2;|
| No Intervention: Usual Care (UC)<br>All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1C (HbA1c) | HbA1c will be extracted from home A1c kits. | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Eligible for Participation in Trial who Enroll |  | Up to Month 12 | 
| Percentage of PCP Practices Eligible for Participation in Trial that Enroll |  | Up to Month 12 | 
| Percentage of Providers who View PRO Reports |  | Up to Month 12 | 
| Percentage of Patients who Respond to PRO Text Messages |  | Up to Month 12 | 
| Percentage of Patients who View PRO Interactive Dashboard |  | Up to Month 12 | 
| Mean Number of EHR Reports Viewed by Providers |  | Up to Month 12 | 
| Total Number of EHR Reports Viewed by Providers |  | Up to Month 12 | 
| Percentage of PRO Messages Responded To by Patients |  | Up to Month 12 | 
| Mean Number of PRO Messages Responded To by Patients |  | Up to Month 12 | 
| Total Number of PRO Messages Responded To by Patients |  | Up to Month 12 | 
| Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard |  | Up to Month 12 | 
| Total Number of Reports Viewed by Patients via PRO Interactive Dashboard |  | Up to Month 12 |