My Diabetes Care: A Scalability and Usability Study

Vanderbilt University Medical Center

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: My Diabetes Care (MDC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05448105

220629

R01DK131129 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to conduct a prospective, longitudinal study on the My Diabetes Care (MDC) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.

Full description

Up to 90 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care (MDC). My Diabetes Care (MDC) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate and tailored diabetes selfcare information. Patients will be invited by mail 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) version 5.0.8. Study participants will complete questionnaires electronically via email using REDCap at two time points: baseline (T0) and one-month follow-up (T1). Participants will complete a baseline questionnaire (T0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and eHealth literacy. Each participant will have access to MDC for 1 month.

Enrollment: 67 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
• Patient at a participating clinic within Vanderbilt Medical Center or Brigham and Women's Hospital
• Able to speak and read in English or Spanish
• Reliable access to a smartphone or tablet with internet access
• Active patient web portal account (for example, My Health at Vanderbilt or Patient Gateway)

Exclusion criteria

• Have a medical condition that affects your memory or ability to think
• Have severe difficulty seeing or hearing
• Have a medical condition that makes it hard for people to understand what you are saying

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

My Diabetes Care (MDC)

Experimental group

Description:

Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention.

Treatment:

Other: My Diabetes Care (MDC)