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

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Behavioral: MJS Diabetes

• Registration Number: NCT03652389
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-29
• Study Start: 2018-12-18
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MJS DIABETES	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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c Levels from Baesline to Month 12	Baseline, Month 12	Hemoglobin A1c (HbA1c) extracted from patient medical record.

Secondary Outcome Measures

Name	Time	Method
Summary of Diabetes Self-Care Activities (SDSCA) Score	Month 12	The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. For each item, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent performance of diabetes self-care activities.
Michigan Diabetes Knowledge Scale Score	Month 12	20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses and ranges from 0-20; higher scores indicate greater diabetes knowledge.
Interpersonal Processes of Care Score	Month 12	29-item item assessment of participants' experiences talking with doctors during the study. Each item is rated on a Likert scale from 1 (never) to 5 (always). The total score ranges from 29 to 145; higher scores indicate more positive experiences.
Diabetes Self-Efficacy Scale Score	Month 12	12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses and ranges from 0-120; higher scores indicate greater diabetes self-efficacy.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States