Clinical trial NCT01416415: Glaucoma Eye Drop Instillation: Impact of Education
Official title: Glaucoma Eye Drop Instillation: Impact of Education
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma, Open-Angle
Keywords: Glaucoma, Open-Angle
Ophthalmic Solutions, Eye drops
Instructional Films and Videos
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-08-15
Enrollment: 119
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eye drop instillation score
timeFrame: 4 +/- 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
Study officials:
affiliation: Northwestern University Department of Ophthalmology
name: Angelo P Tanna, M.D.
role: PRINCIPAL_INVESTIGATOR
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