Back to resultsEffect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard of care
education
Sponsored by
About this trial
This is an interventional prevention trial for Glaucoma focused on measuring glaucoma, patient educator
Eligibility 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.
Sites / Locations
- Rocky Mountain Lions Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
education
standard of care
Outcomes
Primary Outcome Measures
primary outcome is adherence.
Secondary Outcome Measures
differences between patients randomized to standard of care and education intervention.
differences between dropouts and non-dropouts.
Full Information
NCT ID
NCT00454922
First Posted
March 29, 2007
Last Updated
December 4, 2012
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT00454922
Brief Title
Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
Official Title
Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, patient educator
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
education
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
standard of care
Intervention Type
Behavioral
Intervention Name(s)
standard of care
Intervention Description
no intervention
Intervention Type
Other
Intervention Name(s)
education
Intervention Description
meet with trained glaucoma educator 6 times over life of study
Primary Outcome Measure Information:
Title
primary outcome is adherence.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
differences between patients randomized to standard of care and education intervention.
Time Frame
6 months
Title
differences between dropouts and non-dropouts.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malik Y. Kahook, MD
Organizational Affiliation
Rocky Mountain Lions Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Lions Eye Institute
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
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