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

NCT03652389 | Completed Results

• 1 other identifier: 18-01044
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• HbA1c Level at Baseline

  Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

  Baseline

• HbA1c Level at Month 12

  Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

  Month 12

Secondary Outcomes (43)

• Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

  Baseline

• Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

  Month 3

• Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

  Month 6

• Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

  Month 9

• Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score

  Month 12

Study Arms (2)

MJS DIABETES

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Standard Diabetes Treatment

Interventions

MJS Diabetes BEHAVIORAL

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

MJS DIABETES

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (2)

• Mandal S, Belli HM, Cruz J, Mann D, Schoenthaler A. Analyzing User Engagement Within a Patient-Reported Outcomes Texting Tool for Diabetes Management: Engagement Phenotype Study. JMIR Diabetes. 2022 Nov 14;7(4):e41140. doi: 10.2196/41140.

  PMID: 36374531 DERIVED

• Schoenthaler A, Cruz J, Payano L, Rosado M, Labbe K, Johnson C, Gonzalez J, Patxot M, Patel S, Leven E, Mann D. Investigation of a Mobile Health Texting Tool for Embedding Patient-Reported Data Into Diabetes Management (i-Matter): Development and Usability Study. JMIR Form Res. 2020 Aug 31;4(8):e18554. doi: 10.2196/18554.

  PMID: 32865505 DERIVED

Results Point of Contact

• Title: Antoinette M. Schoenthaler
• Organization: NYU Langone Health

Antoinette.Schoenthaler@nyulangone.org

646-501-3434

Study Officials

• Antoinette Schoenthaler, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: December 18, 2018
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)