mHealth Texting Tool for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen byAntoinette Schoenthaler, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

This trial is for adults with type 2 diabetes who have had uncontrolled blood sugar levels (HbA1c >7%) over the past year, can communicate in English or Spanish, and are willing to send/receive text messages. Their primary care providers must work full-time at certain health centers and see at least five patients with type 2 diabetes.

Inclusion Criteria

I have had type 2 diabetes for over 6 months, my HbA1c level is above 7%, I speak English or Spanish, and I am okay with texting.

I am a full-time primary care provider at a participating FHC and treat at least 5 patients with type 2 diabetes.

Exclusion Criteria

I have had type 2 diabetes for over 6 months, my HbA1c level is above 7%, and I am okay with texting in English or Spanish.

Treatment Details

Interventions

MJS Diabetes (Behavioral Intervention)
Usual Care (Behavioral Intervention)

Trial OverviewThe study tests MJS DIABETES, a mobile platform that uses texting to collect patient-reported data on their condition, provides motivational feedback, and integrates this information into electronic health records for better management of type 2 diabetes compared to usual care.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: MJS DIABETESExperimental Treatment1 Intervention

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 II: Usual CareActive Control1 Intervention

Standard Diabetes Treatment