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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454922
• Other study ID #: 07-0106
• Status: Completed
• Phase: N/A
• First received: March 29, 2007
• Last updated: December 4, 2012
• Start date: October 2007
• Est. completion date: January 2012

Study information

• Verified date: October 2008
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glaucoma

Intervention

Behavioral:
• standard of care
no intervention

Other:
• education
meet with trained glaucoma educator 6 times over life of study

Locations

Country	Name	City	State
United States	Rocky Mountain Lions Eye Institute	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcome is adherence.		6 months	No
Secondary	differences between patients randomized to standard of care and education intervention.		6 months	No
Secondary	differences between dropouts and non-dropouts.		6 months	No