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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00454922
First received: March 29, 2007
Last updated: December 4, 2012
Last verified: October 2008
  Purpose

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.


Condition Intervention
Glaucoma
Behavioral: standard of care
Other: education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • primary outcome is adherence. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • differences between patients randomized to standard of care and education intervention. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • differences between dropouts and non-dropouts. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
education
Other: education
meet with trained glaucoma educator 6 times over life of study
Placebo Comparator: 2
standard of care
Behavioral: standard of care
no intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454922

Locations
United States, Colorado
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Malik Y. Kahook, MD Rocky Mountain Lions Eye Institute
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00454922     History of Changes
Other Study ID Numbers: 07-0106
Study First Received: March 29, 2007
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
glaucoma
patient educator

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014