- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421859
Augmented Reality Mobile Application for Glaucoma Education in the South Bronx
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10457
- BronxCare Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EyeCU App
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.
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Augmented reality glaucoma education mobile phone application
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Questionnaire Scores
Time Frame: From date of intervention to date of post-intervention NEHEP glaucoma knowledge test, assessed up to 2 months
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Scores of pre- and post-intervention NEHEP glaucoma knowledge questionnaires will be compared
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From date of intervention to date of post-intervention NEHEP glaucoma knowledge test, assessed up to 2 months
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Change in Follow Up Adherence
Time Frame: Before and 6 months after intervention
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Attendance rate at glaucoma follow-ups will be collected from electronic medical record
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Before and 6 months after intervention
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Change in Medication Adherence
Time Frame: Before and 6 months after intervention
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Self-reported adherence to glaucoma medications will be collected from electronic medical record
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Before and 6 months after intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11141902
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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