- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00756184
Value of an Intervention to Enhance Adherence in Glaucoma Patients
September 27, 2011 updated by: AGP Konstas, Aristotle University Of Thessaloniki
1-year Randomized Control Trial Investigating the Value of an Intervention to Enhance Adherence in Glaucoma Patients Receiving Prostaglandin Monotherapy and in Patients Who Are Candidates for Adjunctive Therapy
A one-year, randomized, attention placebo-controlled trial investigating the value of comprehensive adherence specific interventions, over the course of one year, to enhance adherence in both (a) newly diagnosed open-angle glaucoma, or ocular hypertension patients, naive to medical therapy and (b) those who have failed monotherapy with any prostaglandin analogue (and are therefore candidates for adjunctive therapy) who then are randomized to receive only travoprost monotherapy.
Subjects will be randomized to two different interventions involving direct physician education, each of which will take approximately the same amount of physician time: The first will be intensive adherence education that will continue throughout the year.
The second will be intensive eye care education, but without any direct adherence education.
All patients participating in the study will be monitored for adherence by the TDA.
The study will demonstrate for the first time the role of adherence-specific training in improving patient adherence and will validate the TDA in monitoring and improving adherence in glaucoma.
This will correlate with prior work that has documented that greater adherence is associated with marked improvement in intraocular pressure (IOP) control.
A second goal will be seeing whether improving adherence will change the course of glaucoma therapy by making therapeutic failures into therapeutic successes by reducing the need for adjunctive therapy using only monotherapy with travoprost.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Newly diagnosed patients with glaucoma
- Suboptimally controlled patients with glaucoma
- Untreated baseline IOP greater than 21 mm Hg but less than 32 mm Hg
- Patients who have not responded satisfactorily to PGA therapy
- Patients who are about to have adjunctive therapy administered
- Patients who consent to participate in this trial
Exclusion Criteria:
- Glaucoma patients with high pressure
- Advanced glaucoma
- Patients with side effects to PGA therapy
- Unwilling to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Intervention will consist of intensive teaching on the nature of glaucoma, value of IOP control, need to adhere to medical therapy and counseling on the proper use of travoprost eye drops.
|
monitoring adherence to travoprost therapy
Other Names:
|
Placebo Comparator: B
Intervention with travoprost therapy and TDA monitoring.
Patients of this arm will also be prescribed travoprost and will be followed up in a standard clinical fashion.
This group will receive a comparable amount of personal physician attention, but will not be given adherence, or glaucoma education and will not be told that their adherence will be monitored.
Their attention placebo intervention will discuss the importance and techniques of good "eye health" (sunglasses, vitamins, cataract development, etc but no details, or discussion of either glaucoma or adherence) will insure that the study results are not a result of a change in physician attention to a patient, per se, rather than adherence training.
|
Patients will be prescribed travoprost therapy and will be followed up in a standard clinical fashion with a attention placebo at both baseline and 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adherence rate between intervention and control groups
Time Frame: 1,3,6,12 months
|
1,3,6,12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IOP control
Time Frame: 12 months
|
Monitoring of morning IOP control between the active and the control groups
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anastasios G Konstas, MD, PhD, Glaucoma Unit, 1st University Dept AUT
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
September 19, 2008
First Submitted That Met QC Criteria
September 19, 2008
First Posted (Estimate)
September 22, 2008
Study Record Updates
Last Update Posted (Estimate)
September 28, 2011
Last Update Submitted That Met QC Criteria
September 27, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A5133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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