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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652389
• Other study ID #: 18-01044
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type2 Diabetes

Intervention

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
• Usual Care
Standard Diabetes Treatment

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in the levels of HbA1c	efficacy of the adapted MJS DIABETES versus UC	Baseline
Primary	reduction in the levels of HbA1c	efficacy of the adapted MJS DIABETES versus UC	12 Months