My Diabetes Care: A Scalability and Usability Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 67
- Locations
- 4
- Primary Endpoint
- User Experience - Acceptance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
User Experience - Acceptance
Time Frame: One month follow-up (t1)
User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). Survey items will assess agreement on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Participants will be asked whether they would continue to use My Diabetes Care (MDC) going forward were it to remain available and whether they would recommend MDC to other patients with diabetes.
Usability
Time Frame: One month follow-up (t1)
The System Usability Scale (SUS) is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 71 or above suggests 'good' usability.
System Usage
Time Frame: One month follow-up (t1)
System usage will be assessed by user analytics data capturing participant use to MDC during the study period. MDC use is defined as one or more visits to the MDC site during the study period.
Secondary Outcomes
- Change in Diabetes Knowledge(Baseline (t0) to one month follow-up (t1))
- Change in Diabetes Self-Care - Diet Adherence(Baseline (t0) to one month follow-up (t1))
- Change in Diabetes Self-Care - Exercise Adherence(Baseline (t0) to one month follow-up (t1))
- Change in Diabetes Self-Care - Glucose Self-monitoring Adherence(Baseline (t0) to one month follow-up (t1))
- Change in Diabetes Self-Efficacy(Baseline (t0) to one month follow-up (t1))
- Change in Medication Adherence(Baseline (t0) to one month follow-up (t1))
- Change in Diabetes Distress(Baseline (t0) to one month follow-up (t1))
- Change in Knowledge of Diabetes Measures(Baseline (t0) to one month follow-up (t1))
- Change in Diabetes Readiness for Change(Baseline (t0) to one month follow-up (t1))
Investigators
William Martinez, MD, MS
Assistant Professor of Medicine
Vanderbilt University Medical Center