Clinical trial NCT05448105: My Diabetes Care: A Scalability and Usability Study
Official title: My Diabetes Care: A Scalability and 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: 2022-07-07
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 (MDC) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability
timeFrame: One month follow-up (t1)
measure: System Usage
timeFrame: One month follow-up (t1)
measure: User Experience - Acceptance
timeFrame: One month follow-up (t1)
Secondary outcomes:
measure: Change in Diabetes Knowledge
timeFrame: Baseline (t0) to one month follow-up (t1)
measure: Change in Diabetes Self-Care - Diet Adherence
timeFrame: Baseline (t0) to one month follow-up (t1)
measure: Change in Diabetes Self-Care - Exercise Adherence
timeFrame: Baseline (t0) to one month follow-up (t1)
measure: Change in Diabetes Self-Care - Glucose Self-monitoring Adherence
timeFrame: Baseline (t0) to one month follow-up (t1)
measure: Change in Diabetes Self-Efficacy
timeFrame: Baseline (t0) to one month follow-up (t1)
measure: Change in Medication Adherence
timeFrame: Baseline (t0) to one month follow-up (t1)
measure: Change in Diabetes Distress
timeFrame: Baseline (t0) to one month follow-up (t1)
measure: Change in Knowledge of Diabetes Measures
timeFrame: Baseline (t0) to one month follow-up (t1)
measure: Change in Diabetes Readiness for Change
timeFrame: Baseline (t0) to one month follow-up (t1)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
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: