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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652389
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: MJS Diabetes Behavioral: Usual Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. reduction in the levels of HbA1c [ Time Frame: Baseline ]
    efficacy of the adapted MJS DIABETES versus UC

  2. reduction in the levels of HbA1c [ Time Frame: 12 Months ]
    efficacy of the adapted MJS DIABETES versus UC


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Devin Mann 212 263 4205 devin.mann@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Devin Mann    212-263-4205    devin.mann@nyumc.org   
Principal Investigator: Antoinette Schoenthaler, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Antoinette Schoenthaler, MD NYU Langone Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03652389    
Other Study ID Numbers: 18-01044
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases