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Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients

NCT ID: NCT00454922

Last Updated: 2012-12-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-01-31

Brief Summary

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Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication, which may result in loss of vision, is known to be prevalent. Available information regarding adherence to prescribed medical therapy suggests that some apparent treatment failures may actually be due to non-adherence. The investigators' specific aim is to conduct a study that will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma therapy. The investigators' hypothesis is that patient education and counseling delivered by a trained glaucoma educator, through both planned visits and telephone contacts, will increase adherence to topical glaucoma therapy.

Detailed Description

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Conditions

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Glaucoma

Keywords

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glaucoma patient educator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

education

Group Type ACTIVE_COMPARATOR

education

Intervention Type OTHER

meet with trained glaucoma educator 6 times over life of study

2

standard of care

Group Type PLACEBO_COMPARATOR

standard of care

Intervention Type BEHAVIORAL

no intervention

Interventions

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standard of care

no intervention

Intervention Type BEHAVIORAL

education

meet with trained glaucoma educator 6 times over life of study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary or secondary open angle glaucoma.
* Currently on monotherapy drop treatment for glaucoma.
* Age \> 18 years.
* Patient has presented for care at the Rocky Mountain Lions Eye Institute Glaucoma Center.

Exclusion Criteria

* Inability to independently administer eye drops due to physical disability as reported by the patient.
* Cognitive impairment that would interfere with the ability to self-administer medications as evidenced by a TICS score \< 16.
* Patients who demonstrate \> 80% adherence to glaucoma treatment during the 30 day run-in period.
* It is anticipated that the patient will require glaucoma surgery within the next six months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malik Y. Kahook, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Lions Eye Institute

Locations

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Rocky Mountain Lions Eye Institute

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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07-0106

Identifier Type: -

Identifier Source: org_study_id