NCT03652389

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-18
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2018-08-29
• Last updated: 2025-02-19
• Results posted: 2025-02-19

Locations

1 site across 1 country: United States