Overview

This trial is active, not recruiting.

Condition glaucoma, open-angle
Treatments video education on proper eye drop instillation technique, placebo video education on healthy eating tips
Sponsor Northwestern University
Start date August 2011
End date June 2018
Trial size 100 participants
Trial identifier NCT01416415, NU 00051931

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
The educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique.
video education on proper eye drop instillation technique
The video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops.
(Placebo Comparator)
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.
placebo video education on healthy eating tips
The video is approximately seven minutes long and teaches tips to promote healthy eating.

Primary Outcomes

Measure
Eye drop instillation score
time frame: 4 +/- 3 months

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

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

Additional Information

Official title Glaucoma Eye Drop Instillation: Impact of Education
Principal investigator Angelo P Tanna, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Northwestern University.