Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients - Full Text View

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

This study is currently recruiting participants.
Verified by University of Colorado at Denver and Health Sciences Center, October 2007

Sponsored by:	University of Colorado at Denver and Health Sciences Center
Information provided by:	University of Colorado at Denver and Health Sciences Center
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. Our specific aim is to conduct a study that will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma therapy. Our 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

Genetics Home Reference related topics:

early-onset glaucoma

MedlinePlus related topics:

Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

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
1: Active Comparator education	Other: education meet with trained glaucoma educator 6 times over life of study
2: Placebo Comparator 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: Tim Byrne	720-848-5051	tim.byrne@uchsc.edu

Contact: Malik Y. Kahook, MD	720-848-5029	malik.kahook@uchsc.edu

Locations


United States, Colorado
	Rocky Mountain Lions Eye Institute	Recruiting
	Aurora, Colorado, United States, 80045
	Contact: Tim Byrne 720-848-5051 tim.byrne@uchsc.edu
	Contact: Malik Y. Kahook, MD 720-848-5029 malik>kahook@uchsc.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 at Denver and Health Sciences Center

Investigators


Principal Investigator:	Malik Y. Kahook, MD	Rocky Mountain Lions Eye Institute

More Information

Study ID Numbers:	myk07-0106
First Received:	March 29, 2007
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00454922
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado at Denver and Health Sciences Center:

glaucoma

patient educator

Study placed in the following topic categories:

Glaucoma

Eye Diseases

Hypertension

Ocular Hypertension

ClinicalTrials.gov processed this record on October 22, 2008