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CompletedNCT00454922Updated Dec 6, 2012

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

An interventional study of standard of care and education in Glaucoma, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-06.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma

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Keywords

  • glaucoma
  • patient educator
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 44 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    1

    education

    Other: education

  • Placebo comparator
    2

    standard of care

    Behavioral: standard of care

Interventions

  • Behavioralstandard of care

    no intervention

  • Othereducation

    meet with trained glaucoma educator 6 times over life of study

06

What researchers measure

Primary outcomes

  1. primary outcome is adherence.

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. differences between dropouts and non-dropouts.

    Time frame: 6 months

07

Study locations

1 site
  • Rocky Mountain Lions Eye Institute
    Aurora, Colorado 80045, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00454922
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Apr 2, 2007
Start date
Oct 2007
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Dec 6, 2012

Study contacts

Malik Y. Kahook, MD
principal investigator · Rocky Mountain Lions Eye Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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