i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- HbA1c Level at Baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
HbA1c Level at Baseline
Time Frame: Baseline
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.
HbA1c Level at Month 12
Time Frame: Month 12
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.
Secondary Outcomes
- Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score(Month 12)
- Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score(Month 12)
- Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score(Month 12)
- Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score(Month 12)
- Michigan Diabetes Knowledge Scale Score(Month 12)
- Diabetes Self-Efficacy Scale Score(Month 12)
- Interpersonal Processes of Care Score Communication Subscale Score(Month 12)
- Interpersonal Processes of Care: Decision Making Subscale Score(Month 12)
- Interpersonal Processes of Care: Inter-personal Style Subscale Score(Month 12)