Clinical trial NCT03652389: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: HbA1c Level at Baseline
timeFrame: Baseline
measure: HbA1c Level at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
timeFrame: Baseline
measure: Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
timeFrame: Month 3
measure: Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
timeFrame: Month 6
measure: Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
timeFrame: Month 9
measure: Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
timeFrame: Month 12
measure: Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
timeFrame: Baseline
measure: Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
timeFrame: Month 3
measure: Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
timeFrame: Month 6
measure: Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
timeFrame: Month 9
measure: Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
timeFrame: Month 12
measure: Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
timeFrame: Baseline
measure: Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
timeFrame: Month 3
measure: Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
timeFrame: Month 6
measure: Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
timeFrame: Month 9
measure: Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
timeFrame: Month 12
measure: Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
timeFrame: Baseline
measure: Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
timeFrame: Month 3
measure: Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
timeFrame: Month 6
measure: Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
timeFrame: Month 9
measure: Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
timeFrame: Month 12
measure: Michigan Diabetes Knowledge Scale Score
timeFrame: Baseline
measure: Michigan Diabetes Knowledge Scale Score
timeFrame: Month 6
measure: Michigan Diabetes Knowledge Scale Score
timeFrame: Month 12
measure: Diabetes Self-Efficacy Scale Score
timeFrame: Baseline
measure: Diabetes Self-Efficacy Scale Score
timeFrame: Month 3
measure: Diabetes Self-Efficacy Scale Score
timeFrame: Month 6
measure: Diabetes Self-Efficacy Scale Score
timeFrame: Month 9
measure: Diabetes Self-Efficacy Scale Score
timeFrame: Month 12
measure: Interpersonal Processes of Care Score Communication Subscale Score
timeFrame: Baseline
measure: Interpersonal Processes of Care Score Communication Subscale Score
timeFrame: Month 3
measure: Interpersonal Processes of Care Score Communication Subscale Score
timeFrame: Month 6
measure: Interpersonal Processes of Care Score Communication Subscale Score
timeFrame: Month 9
measure: Interpersonal Processes of Care Score Communication Subscale Score
timeFrame: Month 12
measure: Interpersonal Processes of Care: Decision Making Subscale Score
timeFrame: Baseline
measure: Interpersonal Processes of Care: Decision Making Subscale Score
timeFrame: Month 3
measure: Interpersonal Processes of Care: Decision Making Subscale Score
timeFrame: Month 6
measure: Interpersonal Processes of Care: Decision Making Subscale Score
timeFrame: Month 9
measure: Interpersonal Processes of Care: Decision Making Subscale Score
timeFrame: Month 12
measure: Interpersonal Processes of Care: Inter-personal Style Subscale Score
timeFrame: Baseline
measure: Interpersonal Processes of Care: Inter-personal Style Subscale Score
timeFrame: Month 3
measure: Interpersonal Processes of Care: Inter-personal Style Subscale Score
timeFrame: Month 6
measure: Interpersonal Processes of Care: Inter-personal Style Subscale Score
timeFrame: Month 9
measure: Interpersonal Processes of Care: Inter-personal Style Subscale Score
timeFrame: Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Antoinette Schoenthaler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.