Partnership for Glaucoma

January 3, 2014 updated by: Duke University

Expanding Quality Care for Glaucoma Through a Provider-Patient Partnership

The purpose of this study is to develop new ways of assisting patients with glaucoma and their eye doctors in using the recommendations from practice guidelines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glaucoma is a leading cause of blindness and visual impairment in the United States, particularly among disadvantaged populations. Despite the presence of therapies proven in NEI, randomized controlled trials that can be delivered by more than 18,000 ophthalmologists and 34,000 optometrists, almost nothing is known about the content and quality of glaucoma care delivered by non-MD providers such as optometrists. With the numbers of people with glaucoma expected to more than double in the next twenty years in the face of no more than a 15% increase in the supply of eye care providers, methods to better support appropriate and high-quality care for chronic eye diseases such as glaucoma delivered by optometrists will become as critical, if not more so, as techniques to enhance quality care among ophthalmologists.

Our study is a community-based, randomized, controlled trial that evaluates the suitability and effectiveness of a technology-based (tablet computer) intervention within the context of a novel partnership between optometrists and patients with glaucoma to improve the process quality of care and ultimately outcomes of care. By using successfully implemented technology in novel applications,and by building on the success of ongoing community-based quality improvement projects in our region, the study provides a means for rapid translation into community care if the intervention is successful.

Study Type

Interventional

Enrollment (Actual)

721

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35204
        • University of Alabama
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Diagnosis of open angle glaucoma with documented visual field loss.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Other: Computer Tablet
A tablet computer based software application designed to collect structured clinical information from providers and patients at the point of care.
Other: Continuing Education Course
Annual standard continuing education
Other: 2
Control group to receive annual continuing education
Other: Continuing education
Annual standard continuing education materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if innovative technology will improve process quality of care & important outcomes of care by optometrists in a cost-efficient manner while simultaneously empowering & including patients as part of the care process.
Time Frame: Baseline, Year 1 and Year 2
Baseline, Year 1 and Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Paul Lee, MD, JD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2007

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 4, 2008

First Submitted That Met QC Criteria

May 4, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00002593
  • R01EY018405-01 (U.S. NIH Grant/Contract)

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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