The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

March 7, 2016 updated by: Steven L. Mansberger, Legacy Health System
This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect diabetic retinopathy when compared to traditional surveillance methods, 2) identify the health belief factors related to adherence with annual diabetic eye exams, and 3) determine the cost-effectiveness of the telemedicine system from the perspective of the community clinic, the third-party payer, and the individual patient.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

567

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

    • Kansas
      • Wichita, Kansas, United States, 67214
        • Hunter Health Clinic
    • Oregon
      • Pendleton, Oregon, United States, 97801
        • Yellowhawk Tribal Health Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diabetic, at least 18 years old, patient at a participating health clinic

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine
Participants in this group have digital images of their retina captured with a non-mydriatic camera and are encouraged to see an eye care provider yearly.
Participants receiving the intervention have digital images of their retina captured with a non-mydriatic camera. The images are then sent to Devers Eye Institute for review and report generation.
No Intervention: Traditional Surveillance
Participants in this group are encouraged to see an eye care provider each year for a diabetic eye exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants that Receive Annual Eye Exam
Time Frame: Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study)
This outcome measure will be used to determine (1) whether the telemedicine system increases the proportion of participants that receive an annual eye exam, and (2) what health belief factors are associated with adherence.
Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Steven L Mansberger, MD, MPH, Legacy Health System, Devers Eye Institute
  • Principal Investigator: Thomas M Becker, MD, PhD, Oregon Health and Science 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.

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

August 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

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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