i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management

Study Overview
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Brief Summary
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This study will integrate a technology-based patient-reported outcome (PRO) system [herein MJS DIABETES] that incorporates patients' perspective of their disease and functional status into the management of type 2 diabetes (T2D) in primary care practices. MJS DIABETES is an innovative mobile platform that utilizes text-messaging to capture patients' self-reported PROs in real-time; enhance patient engagement through data-driven feedback and motivational messages; and create dynamic visualizations of the PROs that can be shared in printed reports, and integrated into the EHR; thus making it actionable for patients and their PCPs. Using a mixed-methods design, this study will be conducted in 2 phases: 1) a formative phase, using the evidence-based user-centered design approach; and 2) a clinical-efficacy phase. For the formative phase, a qualitative research method will be used to: a) adapt MJS to the needs of PCPs and T2D patients; b) integrate MJS DIABETES into the EHR system, the primary care practice and the lives of patients with T2D; and c) evaluate the usability of MJS DIABETES in a subset of T2D patients and their PCPs in order to optimize the tool's performance and workflow integration. For the clinical efficacy phase, a randomized control trial will be used to identify the efficacy of MJS DIABETES versus Usual Care (UC) on reduction HbA1c at 12-months, among 282 patients with T2D who receive care in safety-net practices.

Official Title
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i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Behavioral: MJS Diabetes
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Care Provider Inclusion Criteria: Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers (FHCs) and, Provide care to at least five patients with a diagnosis of T2D. Patient Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MJS DIABETES<br>will receive and respond to daily PROs via ttext messages and report SMBG (if insulin-dependent) over the course of the 12-month study. | Behavioral: MJS Diabetes<br>* patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs<br>|
| Active Comparator: Usual Care<br>Standard Diabetes Treatment | Behavioral: Usual Care<br>* Standard Diabetes Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in the levels of HbA1c | efficacy of the adapted MJS DIABETES versus UC | Baseline | 
| reduction in the levels of HbA1c | efficacy of the adapted MJS DIABETES versus UC | 12 Months |