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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Other: education; Behavioral: standard of care

• Registration Number: NCT00454922
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2007-03-29
• Study First Submitted QC: 2007-03-29
• Study First Posted: 2007-04-02
• Study Start: 2007-10
• Status Verified: 2008-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	education	education
2	standard of care	standard of care

Primary Outcome Measures

Name	Time	Method
primary outcome is adherence.	6 months

Secondary Outcome Measures

Name	Time	Method
differences between patients randomized to standard of care and education intervention.	6 months
differences between dropouts and non-dropouts.	6 months

Trial Locations

Locations (1)

Rocky Mountain Lions Eye Institute; 🇺🇸 Aurora, Colorado, United States