Glaucoma Eye Drop Instillation: Impact of Education

Glaucoma, Open-Angle Clinical Trial

Official title:

Glaucoma Eye Drop Instillation: Impact of Education

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01416415
• Other study ID #: NU 00051931
• Status: Terminated
• Phase: N/A
• First received: August 11, 2011
• Last updated: April 3, 2018
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 119
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

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 video education on healthy eating tips
The video is approximately seven minutes long and teaches tips to promote healthy eating.

Locations

Country	Name	City	State
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (17)

Dietlein TS, Jordan JF, Lüke C, Schild A, Dinslage S, Krieglstein GK. Self-application of single-use eyedrop containers in an elderly population: comparisons with standard eyedrop bottle and with younger patients. Acta Ophthalmol. 2008 Dec;86(8):856-9. doi: 10.1111/j.1755-3768.2007.01155.x. Epub 2008 May 20. — View Citation

Djafari F, Lesk MR, Harasymowycz PJ, Desjardins D, Lachaine J. Determinants of adherence to glaucoma medical therapy in a long-term patient population. J Glaucoma. 2009 Mar;18(3):238-43. doi: 10.1097/IJG.0b013e3181815421. — View Citation

Friedman DS, Hahn SR, Quigley HA, Kotak S, Kim E, Onofrey M, Eagan C, Mardekian J. Doctor-patient communication in glaucoma care: analysis of videotaped encounters in community-based office practice. Ophthalmology. 2009 Dec;116(12):2277-85.e1-3. doi: 10.1016/j.ophtha.2009.04.052. Epub 2009 Sep 10. — View Citation

Gelb L, Friedman DS, Quigley HA, Lyon DW, Tan J, Kim EE, Zimmerman TJ, Hahn SR. Physician beliefs and behaviors related to glaucoma treatment adherence: the Glaucoma Adherence and Persistency Study. J Glaucoma. 2008 Dec;17(8):690-8. doi: 10.1097/IJG.0b013e31816b3001. — View Citation

Gold DT, McClung B. Approaches to patient education: emphasizing the long-term value of compliance and persistence. Am J Med. 2006 Apr;119(4 Suppl 1):S32-7. Review. — View Citation

Gurwitz JH, Glynn RJ, Monane M, Everitt DE, Gilden D, Smith N, Avorn J. Treatment for glaucoma: adherence by the elderly. Am J Public Health. 1993 May;83(5):711-6. — View Citation

Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. — View Citation

Kulkarni SV, Damji KF, Buys YM. Medical management of primary open-angle glaucoma: Best practices associated with enhanced patient compliance and persistency. Patient Prefer Adherence. 2008 Feb 2;2:303-14. — View Citation

Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. — View Citation

Nemesure B, Honkanen R, Hennis A, Wu SY, Leske MC; Barbados Eye Studies Group. Incident open-angle glaucoma and intraocular pressure. Ophthalmology. 2007 Oct;114(10):1810-5. Epub 2007 Jun 20. — View Citation

Patel SC, Spaeth GL. Compliance in patients prescribed eyedrops for glaucoma. Ophthalmic Surg. 1995 May-Jun;26(3):233-6. — View Citation

Rotchford AP, Murphy KM. Compliance with timolol treatment in glaucoma. Eye (Lond). 1998;12 ( Pt 2):234-6. — View Citation

Schwartz GF. Compliance and persistency in glaucoma follow-up treatment. Curr Opin Ophthalmol. 2005 Apr;16(2):114-21. Review. — View Citation

The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol. 2000 Oct;130(4):429-40. — View Citation

The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):498-505. — View Citation

Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma. 2003 Oct;12(5):393-8. — View Citation

Vakil N. Increasing compliance with long-term therapy: avoiding complications and adverse events. Rev Gastroenterol Disord. 2005;5 Suppl 2:S12-7. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 +/- 3 months