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Glaucoma Eye Drop Instillation: Impact of Education

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01416415
Recruitment Status : Terminated (Not practical to continue due interim results)
First Posted : August 15, 2011
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Angelo Tanna, Northwestern University

Tracking Information
First Submitted Date  ICMJE August 11, 2011
First Posted Date  ICMJE August 15, 2011
Last Update Posted Date April 5, 2018
Study Start Date  ICMJE August 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glaucoma Eye Drop Instillation: Impact of Education
Official Title  ICMJE Glaucoma Eye Drop Instillation: Impact of Education
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Glaucoma, Open-Angle
Intervention  ICMJE
  • 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.
  • Other: Placebo video education on healthy eating tips
    The video is approximately seven minutes long and teaches tips to promote healthy eating.
Study Arms  ICMJE
  • Experimental: Educational intervention
    The educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique.
    Intervention: Other: Video education on proper eye drop instillation technique
  • 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.
    Intervention: Other: Placebo video education on healthy eating tips
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 3, 2018)
119
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2011)
100
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01416415
Other Study ID Numbers  ICMJE NU 00051931
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angelo Tanna, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Angelo P Tanna, M.D. Northwestern University Department of Ophthalmology
PRS Account Northwestern University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP