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The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT01364129
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : March 9, 2016
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Oregon Health and Science University
Information provided by (Responsible Party):
Steven L. Mansberger, Legacy Health System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Procedure: Ophthalmic Telemedicine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
Study Start Date : August 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Procedure: Ophthalmic Telemedicine
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364129


Locations
United States, Kansas
Hunter Health Clinic
Wichita, Kansas, United States, 67214
United States, Oregon
Yellowhawk Tribal Health Center
Pendleton, Oregon, United States, 97801
Sponsors and Collaborators
Legacy Health System
Centers for Disease Control and Prevention
Oregon Health and Science University
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven L. Mansberger, MD, MPH, Legacy Health System
ClinicalTrials.gov Identifier: NCT01364129     History of Changes
Other Study ID Numbers: NPAIHB O5-P-O5
1-U-48-DP-002673 ( Other Grant/Funding Number: CDC )
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016

Keywords provided by Steven L. Mansberger, Legacy Health System:
Diabetes
Diabetic Retinopathy Screening
Ophthalmic Telemedicine
Comparative Effectiveness Research

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases