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Glaucoma Eye Drop Instillation: Impact of Education

Primary Purpose

Glaucoma, Open-Angle

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video education on proper eye drop instillation technique
Placebo video education on healthy eating tips
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma, Open-Angle focused on measuring Glaucoma, Open-Angle, Ophthalmic Solutions, Eye drops, Instructional Films and Videos

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Medical Faculty Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Educational intervention

Attention placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2011
Last Updated
April 3, 2018
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01416415
Brief Title
Glaucoma Eye Drop Instillation: Impact of Education
Official Title
Glaucoma Eye Drop Instillation: Impact of Education
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Not practical to continue due interim results
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
Glaucoma, Open-Angle, Ophthalmic Solutions, Eye drops, Instructional Films and Videos

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
The educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique.
Arm Title
Attention placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Video education on proper eye drop instillation technique
Intervention Description
The video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops.
Intervention Type
Other
Intervention Name(s)
Placebo video education on healthy eating tips
Intervention Description
The video is approximately seven minutes long and teaches tips to promote healthy eating.
Primary Outcome Measure Information:
Title
Eye drop instillation score
Description
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.
Time Frame
4 +/- 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo P Tanna, M.D.
Organizational Affiliation
Northwestern University Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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19920977
Citation
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PubMed Identifier
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Glaucoma Eye Drop Instillation: Impact of Education

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