Glaucoma Eye Drop Instillation: Impact of Education

Study Overview
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Brief Summary
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The purpose of this study is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. The investigators predict that the educational intervention will have a positive impact on the efficacy, safety, and efficiency with which patients administer their eye drops.

Detailed Description
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Glaucoma is a leading cause of irreversible vision loss worldwide, and as such has a large public health impact. The only treatment proven to slow or arrest the progression of the disease process is intraocular pressure (IOP) reduction, which relies heavily on patient cooperation. Previously, nonadherence to glaucoma medications has ranged from 24% to 59%. Barriers to medication compliance in the glaucoma patient population include health literacy, poor comprehension of disease, poor comprehension of medication regimen, and improper eye drop administration technique. The purpose of this randomized, controlled clinical trial is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. Patients randomized to the experimental group will receive the educational intervention, consisting of an instructional video demonstrating how to instill eyedrops. Patients randomized to the control group will receive an attention placebo, consisting of a video regarding healthy eating tips. Additional measures that will be obtained from all patients include a health literacy score, as measured using the REALM questionnaire, and a BMQ - specific score (Beliefs about Medicines Questionnaire) using the BMQ-specific questionnaire. If the education protocol is found to positively affect eye drop administration success, as demonstrated by a statistically significant difference between the experimental and control groups, suggestions will be proposed for the implementation of educational programs similar to ours to improve glaucoma patient outcomes.

Official Title
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Glaucoma Eye Drop Instillation: Impact of Education

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Other: Video education on proper eye drop instillation technique
* Other: Placebo video education on healthy eating tips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established care with the treating ophthalmologist for at least 6 months Diagnosis of open-angle glaucoma or ocular hypertension The use of one, two or three self-instilled eye drop medications in one or two eyes Age 40-85 years Fluency in English Best corrected visual acuity (BCVA) of 20/50 or better in each eye Exclusion Criteria: Presence of moderate to severe cognitive deficits Presence of a clinically significant tremor Mini Mental Status Exam score ≤ 20

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational intervention<br>The educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique. | Other: Video education on proper eye drop instillation technique<br>* The video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops.<br>|
| Placebo Comparator: Attention placebo<br>The attention control placebo group will receive an educational intervention that mimics the amount of time and attention received by the treatment group. The video chosen is regarding healthy eating tips. | Other: Placebo video education on healthy eating tips<br>* The video is approximately seven minutes long and teaches tips to promote healthy eating.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye drop instillation score | The eye drop instillation score is a composite score of the efficacy, safety, and efficiency with which the subject instills their eyedrops and is simply a measure of how well the subject administers their eyedrops. | 4 +/- 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Open-Angle, Ophthalmic Solutions, Eye drops, Instructional Films and Videos