i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
Primary Purpose
Type2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MJS Diabetes
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Type2 Diabetes
Eligibility 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
Sites / Locations
- New York University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MJS DIABETES
Usual Care
Arm Description
will receive and respond to daily PROs via ttext messages and report SMBG (if insulin-dependent) over the course of the 12-month study.
Standard Diabetes Treatment
Outcomes
Primary Outcome Measures
reduction in the levels of HbA1c
efficacy of the adapted MJS DIABETES versus UC
reduction in the levels of HbA1c
efficacy of the adapted MJS DIABETES versus UC
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03652389
Brief Title
i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
Official Title
i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
346 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MJS DIABETES
Arm Type
Experimental
Arm Description
will receive and respond to daily PROs via ttext messages and report SMBG (if insulin-dependent) over the course of the 12-month study.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Standard Diabetes Treatment
Intervention Type
Behavioral
Intervention Name(s)
MJS Diabetes
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Standard Diabetes Treatment
Primary Outcome Measure Information:
Title
reduction in the levels of HbA1c
Description
efficacy of the adapted MJS DIABETES versus UC
Time Frame
Baseline
Title
reduction in the levels of HbA1c
Description
efficacy of the adapted MJS DIABETES versus UC
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Cruz
Phone
6465013474
Email
Jocelyn.Acosta@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette Schoenthaler, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn Cruz
Phone
646-501-3474
Email
Jocelyn.Acosta@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Antoinette Schoenthaler, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Citations:
PubMed Identifier
36374531
Citation
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.
Results Reference
derived
PubMed Identifier
32865505
Citation
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.
Results Reference
derived
Learn more about this trial
i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
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