Clinical trial NCT04894916: My Diabetes Care Mobile: A Usability Study
Official title: The My Diabetes Care Patient Portal Intervention for Mobile Devices: A Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Self-efficacy
Patient Web Portals
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-05-20
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Usability
timeFrame: One-month follow-up
measure: System Usage Data
timeFrame: One-month follow-up
measure: User Experience
timeFrame: One-month follow-up
Secondary outcomes:
measure: Change in Diabetes Knowledge
timeFrame: Baseline to one-month follow-up
measure: Change in Diabetes Self-Efficacy
timeFrame: Baseline to one-month follow-up
measure: Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures
timeFrame: Baseline to one-month follow-up
measure: Change in Diabetes Distress
timeFrame: Baseline to one-month follow-up
measure: Change in Diabetes Attitudes
timeFrame: Baseline to one-month follow-up
measure: Change in Diabetes Readiness for Change
timeFrame: Baseline to one-month follow-up
measure: Change in Diabetes Self-Care (General Diet Adherence)
timeFrame: Baseline to one-month follow-up
measure: Change in Diabetes Self-Care (Specific Diet Adherence)
timeFrame: Baseline to one-month follow-up
measure: Change in Diabetes Self-Care (Exercise Adherence)
timeFrame: Baseline to one-month follow-up
measure: Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
timeFrame: Baseline to one-month Follow-up
measure: Change in Medication Adherence
timeFrame: Baseline to one-month follow-up
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William Martinez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: