Glaucoma Eye Drop Instillation: Impact of Education

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Angelo Tanna, Northwestern University
ClinicalTrials.gov Identifier:
NCT01416415
First received: August 11, 2011
Last updated: April 20, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: July 2015 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416415

Contacts
Contact: Angelo P Tanna, M.D. 312- 908-8152 atanna@northwestern.edu

Locations
United States, Illinois
Northwestern Medical Faculty Foundation Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Angelo P Tanna, M.D.         
Sponsors and Collaborators
Northwestern University
Investigators
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 20, 2014
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
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014