Glaucoma Eye Drop Instillation: Impact of Education

NCT ID: NCT01416415

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Educational intervention

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

Group Type EXPERIMENTAL

Video education on proper eye drop instillation technique

Intervention Type OTHER

The video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops.

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.

Group Type PLACEBO_COMPARATOR

Placebo video education on healthy eating tips

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Placebo video education on healthy eating tips

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Angelo Tanna

Vice Chairman, Department of Ophthalmology and Director, Glaucoma Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angelo P Tanna, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Department of Ophthalmology

Locations

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Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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. doi: 10.2147/ppa.s4163.

Reference Type BACKGROUND
PMID: 19920977 (View on PubMed)

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. doi: 10.1016/j.ophtha.2007.04.003. Epub 2007 Jun 20.

Reference Type BACKGROUND
PMID: 17583352 (View on PubMed)

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. doi: 10.1016/s0002-9394(00)00538-9.

Reference Type BACKGROUND
PMID: 11024415 (View on PubMed)

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. doi: 10.1001/archopht.120.6.701.

Reference Type BACKGROUND
PMID: 12049574 (View on PubMed)

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. doi: 10.1016/s0002-9394(98)00272-4.

Reference Type BACKGROUND
PMID: 9780094 (View on PubMed)

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. doi: 10.1016/s0161-6420(01)00873-9.

Reference Type BACKGROUND
PMID: 11713061 (View on PubMed)

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. doi: 10.1016/j.amjmed.2005.12.021.

Reference Type BACKGROUND
PMID: 16563940 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16369223 (View on PubMed)

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. doi: 10.2105/ajph.83.5.711.

Reference Type BACKGROUND
PMID: 8484454 (View on PubMed)

Schwartz GF. Compliance and persistency in glaucoma follow-up treatment. Curr Opin Ophthalmol. 2005 Apr;16(2):114-21. doi: 10.1097/01.icu.0000156139.05323.26.

Reference Type BACKGROUND
PMID: 15744142 (View on PubMed)

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. doi: 10.1097/00061198-200310000-00001.

Reference Type BACKGROUND
PMID: 14520147 (View on PubMed)

Rotchford AP, Murphy KM. Compliance with timolol treatment in glaucoma. Eye (Lond). 1998;12 ( Pt 2):234-6. doi: 10.1038/eye.1998.56.

Reference Type BACKGROUND
PMID: 9683946 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7651690 (View on PubMed)

Dietlein TS, Jordan JF, Luke 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.

Reference Type BACKGROUND
PMID: 18494743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19295380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19092468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19744715 (View on PubMed)

Other Identifiers

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NU 00051931

Identifier Type: -

Identifier Source: org_study_id

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