Effects of My Diabetes Care on Patient Outcomes

Vanderbilt University Medical Center

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: My Diabetes Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05451914

230106

R01DK131129 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care (MDC), to evaluate its effect on clinical outcomes.

Full description

484 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 242 will be assigned to the intervention (My Diabetes Care) embedded within an existing patient web portal, My Health at Vanderbilt at Vanderbilt University Medical Center or Patient Gateway at Brigham and Women's Hospital. 242 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt or Patient Gateway without the My Diabetes Care (MDC) application. Potentially eligible patients will be invited to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap). Outcomes data will be collected from patients at four time points: baseline (T0), three-month follow-up (T1), three-month follow-up (T2), six-month follow-up (T3), and twelve-month follow-up (T4). At each time point, study participants will complete questionnaires electronically via email using REDCap, participants' hemoglobin A1C level will be assess via home A1C test kits, and participants' diabetes health data will be abstracted from their electronic health record. Participants will be randomized to the intervention or control arm after their baseline data is collected.

Enrollment: 458 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes Mellitus
• Age 18-75 years old
• Currently taking at least one medication for diabetes
• Be a patient at Vanderbilt University Medical Center (VUMC) or Brigham and Women's Hospital (BWH)
• Able to speak and read in English or Spanish
• Have reliable access to a smartphone, tablet, or computer with internet access
• Active patient web portal account (My Health at Vanderbilt at VUMC or Patient Gateway at BWH)

Exclusion criteria

• Receiving dialysis,
• Pregnant or planning to become pregnant within the next year,
• Living in a long-term care facility.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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458 participants in 2 patient groups

My Diabetes Care

Experimental group

Description:

Patients have access to an existing patient web portal (i.e., Epic's MyChart) embedded with My Diabetes Care.

Treatment:

Other: My Diabetes Care

Usual Care

No Intervention group

Description:

Patients will have access to an existing patient web portal (i.e., Epic's MyChart) NOT embedded with My Diabetes Care (i.e., usual care)