My Diabetes Care Mobile: A Usability Study

NCT ID: NCT04894916

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-12
• Study Completion Date: 2021-08-27

Brief Summary

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

Detailed Description

Up to 65 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care mobile (MDC-m). My Diabetes Care mobile (MDC-m) 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), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care 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 an 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 the MDC-m for 1 month.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

My Diabetes Care Mobile (MDC-m)

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

Group Type: EXPERIMENTAL

My Diabetes Care Mobile (MDC-m)

Intervention Type: OTHER

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), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information.

Interventions

My Diabetes Care Mobile (MDC-m)

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), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information.

Intervention Type: OTHER

Other Intervention Names

Patient-facing Diabetes Dashboard

Eligibility Criteria

Inclusion Criteria

• Type 2 Diabetes Mellitus
• Currently taking at least one medication for diabetes
• Age 21 or over
• Able to speak and read in English
• Reliable access to a smartphone or tablet with internet access
• Active VUMC patient web portal (known as My Health At Vanderbilt) account

Exclusion Criteria

• Residing in a long term care facility
• Medical condition that affects my memory or ability to think.
• Severe visual impairment
• Patients with unintelligible speech (e.g., dysarthria)
• Currently participating in another diabetes-related research study

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

William Martinez, MD, MS

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Martinez, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R03DK119735

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202268

Identifier Type: -

Identifier Source: org_study_id