i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MJS DIABETES 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
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
|
| Active Comparator: Usual Care Standard Diabetes Treatment |
Behavioral: Usual Care
Standard Diabetes Treatment
|
Outcome Measures
Primary Outcome Measures
- reduction in the levels of HbA1c [Baseline]
efficacy of the adapted MJS DIABETES versus UC
- reduction in the levels of HbA1c [12 Months]
efficacy of the adapted MJS DIABETES versus UC
Eligibility Criteria
Criteria
Inclusion Criteria:
Primary Care Provider Inclusion Criteria:
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Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers (FHCs) and,
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Provide care to at least five patients with a diagnosis of T2D.
Patient Inclusion Criteria:
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Have a diagnosis of T2D for ≥6 months;
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Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two visits in the past year;
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Fluency in English or Spanish;
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Be willing to send/receive text messages; and
Exclusion Criteria:
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Have a diagnosis of T2D for ≥6 months;
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Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two visits in the past year;
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Fluency in English or Spanish;
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Be willing to send/receive text messages; and
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Antoinette Schoenthaler, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-01044