i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
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|ClinicalTrials.gov Identifier: NCT03652389|
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : December 18, 2018
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|
|Type2 Diabetes||Behavioral: MJS Diabetes Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||346 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
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
- reduction in the levels of HbA1c [ Time Frame: Baseline ]efficacy of the adapted MJS DIABETES versus UC
- reduction in the levels of HbA1c [ Time Frame: 12 Months ]efficacy of the adapted MJS DIABETES versus UC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652389
|Contact: Devin Mann||212 263 firstname.lastname@example.org|
|United States, New York|
|New York University School of Medicine||Not yet recruiting|
|New York, New York, United States, 10016|
|Contact: Devin Mann 212-263-4205 email@example.com|
|Principal Investigator: Antoinette Schoenthaler, MD|
|Principal Investigator:||Antoinette Schoenthaler, MD||New York University School of Medicine|