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Clinical Trials/NCT04894916
NCT04894916CompletedNot Applicable

The My Diabetes Care Patient Portal Intervention for Mobile Devices: A Usability Study

Vanderbilt University Medical Center2 sites in 1 country64 target enrollmentStarted: June 12, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
2
Primary Endpoint
Usability

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Usability

Time Frame: One-month follow-up

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 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).

System Usage Data

Time Frame: One-month follow-up

Self-reported usage of My Diabetes Care to include total number of participants who visited MDC-m during the study period and total number of participants with who used MDC-m for 10 minutes or more during the study period.

User Experience

Time Frame: One-month follow-up

Unique study specific items to assess participants' perspectives on the usefulness of particular My Diabetes Care features and functionality.

Secondary Outcomes

  • Change in Diabetes Readiness for Change(Baseline to one-month follow-up)
  • Change in Medication Adherence(Baseline to one-month follow-up)
  • Change in Number of Participants That Correctly Identified Definitions and Goal Ranges for Diabetes Health Measures(Baseline to one-month follow-up)
  • Change in Diabetes Distress(Baseline to one-month follow-up)
  • Change in Diabetes Knowledge(Baseline to one-month follow-up)
  • Change in Diabetes Self-Efficacy(Baseline to one-month follow-up)
  • Change in Diabetes Attitudes(Baseline to one-month follow-up)
  • Change in Diabetes Self-Care (Specific Diet Adherence)(Baseline to one-month follow-up)
  • Change in Diabetes Self-Care (Exercise Adherence)(Baseline to one-month follow-up)
  • Change in Diabetes Self-Care (General Diet Adherence)(Baseline to one-month follow-up)
  • Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)(Baseline to one-month Follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

William Martinez, MD, MS

Assistant Professor of Medicine

Vanderbilt University Medical Center

Study Sites (2)

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