Glaucoma Eye Drop Instillation: Impact of Education
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma, Open-Angle |
Other: Video education on proper eye drop instillation technique Other: Placebo video education on healthy eating tips |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Glaucoma Eye Drop Instillation: Impact of Education |
- Eye drop instillation score [ Time Frame: 4 +/- 3 months ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Educational intervention
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
The video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops.
|
|
Placebo Comparator: Attention placebo
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
The video is approximately seven minutes long and teaches tips to promote healthy eating.
|
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| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Angelo P Tanna, M.D. | 312- 908-8152 | atanna@northwestern.edu |
| United States, Illinois | |
| Northwestern Medical Faculty Foundation | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Angelo P Tanna, M.D. | |
| Principal Investigator: | Angelo P Tanna, M.D. | Northwestern University Department of Ophthalmology |
More Information
Publications:
| Responsible Party: | Angelo Tanna, Vice Chairman, Department of Ophthalmology and Director, Glaucoma Service, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01416415 History of Changes |
| Other Study ID Numbers: | NU 00051931 |
| Study First Received: | August 11, 2011 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Glaucoma, Open-Angle Ophthalmic Solutions, Eye drops Instructional Films and Videos |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases Tetrahydrozoline Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013