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Clinical Trials/NCT04728620
NCT04728620
Completed
N/A

A Patient Portal Intervention to Address Diabetes Care Gaps: A Usability Study

Vanderbilt University Medical Center1 site in 1 country60 target enrollmentMay 6, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Vanderbilt University Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Usability
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the usability of a novel patient portal intervention designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual diabetes eye exam) become due and (b) allow patients to initiate orders for the care. In addition, the investigators will assess pre-post change on secondary psychosocial outcomes (e.g., self-efficacy).

Detailed Description

Up to 60 adult patients with type 1 or 2 diabetes mellitus will be enrolled and given access to a new feature within the patient portal at Vanderbilt University Medical Center. The new feature will be available via the patient portal native app (i.e., My Health at Vanderbilt (MHAV) app) for mobile devices (smartphone or tablet). The new feature will allow patients to: (1) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (2) initiate an order for the care. Study participants will complete questionnaires electronically via email at three time points: baseline (T0), immediately after first use of the intervention (T1), and three-month follow-up (T2) to as assess study outcomes including usability and pre-post change in secondary psychosocial outcomes.

Registry
clinicaltrials.gov
Start Date
May 6, 2021
End Date
May 25, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William Martinez, MD, MS

Assistant Professor of Medicine

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Established patient at participating primary care clinic
  • Type 1 or 2 diabetes mellitus
  • Able to speak and read in English
  • Age 18 to 75 years old
  • Mobile device (smartphone or tablet) with internet access
  • Active MHAV account and willing and able to use the MHAV native app on a mobile device
  • Due (based on evidence-based guidelines) for any of the following: hemoglobin A1C, urine microalbumin, diabetes eye exam, and/or pneumococcal vaccination.

Exclusion Criteria

  • Known cognitive deficits or functional impairment preventing the use of a mobile device
  • Pregnant or planning to become pregnant during the study period
  • Severe difficulty seeing
  • Severe difficulty hearing
  • Medical condition that make it hard for people to understand what they are saying

Outcomes

Primary Outcomes

Usability

Time Frame: Immediately after first use T(1), at approximately 1 month

The System Usability Scale (SUS) is a validated measure of usability. 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). A score of above 68 indicative of "above average" usability.

User Experience

Time Frame: 3-month follow up (T2)

User experience will be assessed by study-specific survey items administered to all participants at the end of the study period (T2). The survey items will inquire about participants' perspectives on the acceptability of the intervention and on particular components of the intervention such as notifications.

Secondary Outcomes

  • Change in Understanding of Diabetes Monitoring and Preventative Care(Enrollment (T0) and 3-month follow up (T2))
  • Order Completion(3-month follow up (T2))
  • Change in Attitudes Toward Managing Diabetes in General(Enrollment (T0) and 3-month follow up (T2))
  • Patient Initiated Orders(3-month follow up (T2))
  • Change in Diabetes Distress(Enrollment (T0) and 3-month follow up (T2))

Study Sites (1)

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