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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

MJS Diabetes

Intervention Type BEHAVIORAL

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

Usual Care

Standard Diabetes Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No