Skip to main content
Clinical Trials/NCT01416415
NCT01416415TerminatedNot Applicable

Glaucoma Eye Drop Instillation: Impact of Education

Northwestern University1 site in 1 country119 target enrollmentStarted: August 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
119
Locations
1
Primary Endpoint
Eye drop instillation score

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Educational intervention

Experimental

The educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique.

Intervention: Video education on proper eye drop instillation technique (Other)

Attention placebo

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.

Intervention: Placebo video education on healthy eating tips (Other)

Outcomes

Primary Outcomes

Eye drop instillation score

Time Frame: 4 +/- 3 months

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Angelo Tanna

Vice Chairman, Department of Ophthalmology and Director, Glaucoma Service

Northwestern University

Study Sites (1)

Loading locations...

Similar Trials