Clinical trial NCT00756184: Value of an Intervention to Enhance Adherence in Glaucoma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Adherence
Teaching
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2008-09-22
Enrollment: 107
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence rate between intervention and control groups
timeFrame: 1,3,6,12 months
Secondary outcomes:
measure: IOP control
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Glaucoma Unit, 1st University Dept AUT
name: Anastasios G Konstas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: