Value of an Intervention to Enhance Adherence in Glaucoma Patients

NCT00756184 | Completed Phase 4

• 1 other identifier: A5133
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma

Keywords

Glaucoma; Adherence; Teaching

Outcome Measures

Primary Outcomes (1)

• Adherence rate between intervention and control groups

  1,3,6,12 months

Secondary Outcomes (1)

• IOP control

  12 months

Study Arms (2)

A

ACTIVE COMPARATOR

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.

Device: TDA adherence monitor for travoprost therapy

B

PLACEBO COMPARATOR

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.

Device: TDA and travoprost monotherapy

Interventions

TDA adherence monitor for travoprost therapy DEVICE

monitoring adherence to travoprost therapy

Also known as: Adherence and IOP control after 12 months of therapy

A

TDA and travoprost monotherapy DEVICE

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

B

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Glaucoma patients with high pressure
• Advanced glaucoma
• Patients with side effects to PGA therapy
• Unwilling to participate

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Alcon Research: collaborator

MeSH Terms

Conditions

Glaucoma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Anastasios G Konstas, MD, PhD

  Glaucoma Unit, 1st University Dept AUT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Ophthalmology

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: September 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 28, 2011

Record last verified: 2011-09