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



Status:Not yet recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 90
Updated:12/20/2018
Start Date:February 1, 2019
End Date:February 2023
Contact:Devin Mann
Email:devin.mann@nyumc.org
Phone:212 263 4205

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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.


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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Antoinette Schoenthaler, MD
Phone: 212-263-4205
New York University School of Medicine NYU School of Medicine has a proud history that...
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