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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by University of Colorado, Denver. Recruitment status was Recruiting

First Received on March 29, 2007. Last Updated on October 22, 2009 History of Changes

Sponsor:	University of Colorado, Denver
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00454922

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

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

Primary Outcome Measures:

primary outcome is adherence. [ Time Frame: 6 months ]

Secondary Outcome Measures:

differences between patients randomized to standard of care and education intervention. [ Time Frame: 6 months ]
differences between dropouts and non-dropouts. [ Time Frame: 6 months ]

Estimated Enrollment:	100
Study Start Date:	October 2007
Estimated Study Completion Date:	May 2008

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

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

Contacts

Contact: Mary Preston	720-848-2035	mary.preston@ucdenver.edu
Contact: Malik Y. Kahook, MD	720-848-5029	malik.kahook@ucdenver.edu

Locations

United States, Colorado
Rocky Mountain Lions Eye Institute	Recruiting
Aurora, Colorado, United States, 80045
Contact: Mary Preston 720-848-2035 mary.preston@ucdenver.edu
Contact: Malik Y. Kahook, MD 720-848-5029 malik.kahook@ucdenver.edu
Sub-Investigator: Robert W. Bremer, PhD
Sub-Investigator: Paul F. Cook, PhD
Sub-Investigator: L. Miriam Dickinson, PhD
Sub-Investigator: Douglas L. MacKenzie, MD
Sub-Investigator: Naresh Mandava, MD

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator:

Malik Y. Kahook, MD

Rocky Mountain Lions Eye Institute

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00454922 History of Changes
Other Study ID Numbers:	myk07-0106
Study First Received:	March 29, 2007
Last Updated:	October 22, 2009
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 February 09, 2012