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

NCT00454922 | Completed

• 1 other identifier: 07-0106
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma; patient educator

Outcome Measures

Primary Outcomes (1)

• primary outcome is adherence.

  6 months

Secondary Outcomes (2)

• differences between patients randomized to standard of care and education intervention.

  6 months

• differences between dropouts and non-dropouts.

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

education

Other: education

2

PLACEBO COMPARATOR

standard of care

Behavioral: standard of care

Interventions

standard of care BEHAVIORAL

no intervention

2

education OTHER

meet with trained glaucoma educator 6 times over life of study

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Rocky Mountain Lions Eye Institute

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Standard of Care; Educational Status

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Socioeconomic Factors; Population Characteristics

Study Officials

• Malik Y. Kahook, MD

  Rocky Mountain Lions Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: April 2, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2008-10

Locations

US (1)