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Augmented Reality Mobile Application for Glaucoma Education in the South Bronx

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EyeCU Mobile Application
Sponsored by
Bronx-Lebanon Hospital Center Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Patients with a clinical diagnosis of glaucoma on medical therapy for at least 4 months

Exclusion Criteria:

  • Patients with optic neuropathies unrelated to glaucoma
  • Patients with VA 20/100 or worse in both eyes
  • Visual defects involving fixation in both eyes
  • Patients with symptoms impairing ability to operate a smartphone during visit including diplopia, motor difficulties, cognitive impairment, illiteracy
  • Patients who are unable to read or understand English or Spanish

Sites / Locations

  • BronxCare Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EyeCU App

Arm Description

Augmented reality mobile application called "EyeCU" which simulates glaucoma progression and enhances understanding about the disease and its course. It is a bilingual (English/Spanish) application that is free-to-download on the Android and Apple app store. It will be delivered on a hospital owned tablet device and patients will be instructed to complete two sections, taking approximately 10 minutes.

Outcomes

Primary Outcome Measures

Change in Questionnaire Scores
Scores of pre- and post-intervention NEHEP glaucoma knowledge questionnaires will be compared
Change in Follow Up Adherence
Attendance rate at glaucoma follow-ups will be collected from electronic medical record
Change in Medication Adherence
Self-reported adherence to glaucoma medications will be collected from electronic medical record

Secondary Outcome Measures

Full Information

First Posted
May 29, 2020
Last Updated
July 21, 2022
Sponsor
Bronx-Lebanon Hospital Center Health Care System
Collaborators
EyeCU Group, VISRE
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1. Study Identification

Unique Protocol Identification Number
NCT04421859
Brief Title
Augmented Reality Mobile Application for Glaucoma Education in the South Bronx
Official Title
Augmented Reality Mobile Application for Glaucoma Education in the South Bronx
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx-Lebanon Hospital Center Health Care System
Collaborators
EyeCU Group, VISRE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A team at the National Healthcare Group Eye Institute in Singapore have developed an augmented reality mobile phone application, EyeCU, to simulate glaucoma progression and enhance understanding about the disease and its course. It is a bilingual (English/Spanish) application that is free-to-download on the Android and Apple app store. As eye care physicians in the South Bronx, the investigators are hopeful that the findings in this study can be extrapolated to our patients in the South Bronx, where poor health literacy, non-adherence to glaucoma medication and poor follow-up remains a large barrier. The investigators hope that by offering the simulation in both English and Spanish, the investigators will not only be able to improve our patients' understanding of glaucoma, but also improve glaucoma treatment adherence and assess our patient population's responsiveness to augmented reality as an educational platform.
Detailed Description
Experimental design: Pilot cohort study Data collection: Patient characteristics such as age, sex, ethnicity, preferred language, zip code, employment status, highest educational attainment, current topical eye medications, Past Ocular History, Past Medical History Recruitment for participation in the study will be performed during glaucoma clinic registration Consent will be conducted by a member of the research team who is not directly involved in the participant's clinical care Pre-intervention glaucoma knowledge questionnaire (NEHEP glaucoma knowledge questionnaire) will be given to participants, to be completed on dedicated clinic tablet device. Post-intervention glaucoma knowledge questionnaire (NEHEP glaucoma knowledge questionnaire) will be given to participants, to be completed on dedicated clinic tablet device. Rate of missed glaucoma follow-up appointments before and 6 months after application use will be collected from the electronic medical record. Rate of medication adherence before and 6 months after application use will be collected from the electronic medical record.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EyeCU App
Arm Type
Experimental
Arm Description
Augmented reality mobile application called "EyeCU" which simulates glaucoma progression and enhances understanding about the disease and its course. It is a bilingual (English/Spanish) application that is free-to-download on the Android and Apple app store. It will be delivered on a hospital owned tablet device and patients will be instructed to complete two sections, taking approximately 10 minutes.
Intervention Type
Other
Intervention Name(s)
EyeCU Mobile Application
Intervention Description
Augmented reality glaucoma education mobile phone application
Primary Outcome Measure Information:
Title
Change in Questionnaire Scores
Description
Scores of pre- and post-intervention NEHEP glaucoma knowledge questionnaires will be compared
Time Frame
From date of intervention to date of post-intervention NEHEP glaucoma knowledge test, assessed up to 2 months
Title
Change in Follow Up Adherence
Description
Attendance rate at glaucoma follow-ups will be collected from electronic medical record
Time Frame
Before and 6 months after intervention
Title
Change in Medication Adherence
Description
Self-reported adherence to glaucoma medications will be collected from electronic medical record
Time Frame
Before and 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Patients with a clinical diagnosis of glaucoma on medical therapy for at least 4 months Exclusion Criteria: Patients with optic neuropathies unrelated to glaucoma Patients with VA 20/100 or worse in both eyes Visual defects involving fixation in both eyes Patients with symptoms impairing ability to operate a smartphone during visit including diplopia, motor difficulties, cognitive impairment, illiteracy Patients who are unable to read or understand English or Spanish
Facility Information:
Facility Name
BronxCare Health System
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Augmented Reality Mobile Application for Glaucoma Education in the South Bronx

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