- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01364129
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
Conditions
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
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Kansas
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Wichita, Kansas, United States, 67214
- Hunter Health Clinic
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Oregon
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Pendleton, Oregon, United States, 97801
- Yellowhawk Tribal Health Center
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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.
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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.
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No Intervention: Traditional Surveillance
Participants in this group are encouraged to see an eye care provider each year for a diabetic eye exam.
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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)
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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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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- Park DW, Mansberger SL. Eye Disease in Patients with Diabetes Screened with Telemedicine. Telemed J E Health. 2017 Feb;23(2):113-118. doi: 10.1089/tmj.2016.0034. Epub 2016 Jun 21.
- Mansberger SL, Sheppler C, Barker G, Gardiner SK, Demirel S, Wooten K, Becker TM. Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 May;133(5):518-25. doi: 10.1001/jamaophthalmol.2015.1.
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPAIHB O5-P-O5
- 1-U-48-DP-002673 (Other Grant/Funding Number: CDC)
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.
Clinical Trials on Diabetic Retinopathy
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Retina Institute of HawaiiUnknownDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Severe Nonproliferative Diabetic Retinopathy | Mild Nonproliferative Diabetic Retinopathy | Moderate Nonproliferative Diabetic RetinopathyUnited States
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University of CataniaUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyItaly
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Asociación para Evitar la Ceguera en MéxicoCompletedProliferative Diabetic Retinopathy | Severe Nonproliferative | Active Photocoagulated Diabetic RetinopathyMexico
-
Asociación para Evitar la Ceguera en MéxicoUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyMexico
-
Asociación para Evitar la Ceguera en MéxicoUnknownNon Proliferative Diabetic Retinopathy. | Proliferative Diabetic Retinopathy.Mexico
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Valo Health, Inc.RecruitingProliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
-
AEYE Health IncA. Stein Regulatory Affairs Consulting Ltd.RecruitingDiabetic Mellitus | Diabetic Retinopathy, DRUnited States
-
Ocuphire Pharma, Inc.CompletedDiabetic Retinopathy | Diabetic Macular Edema | NPDR - Non Proliferative Diabetic Retinopathy | PDR - Proliferative Diabetic RetinopathyUnited States
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King Khaled Eye Specialist HospitalCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathySaudi Arabia
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Retina Macula InstituteAllerganCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
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AllerganCompletedOcular Hypertension | Glaucoma, Open-AngleUnited States
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NHS Greater Glasgow and ClydeUniversity of Strathclyde; Microsoft CorporationNot yet recruiting
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-
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NHS Greater Glasgow and ClydeUniversity of Strathclyde; Microsoft CorporationCompletedTelemedicine | Reconstructive Surgery | 3 DimensionalUnited Kingdom
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NHS Greater Glasgow and ClydeUniversity of Strathclyde; Glasgow Royal InfirmaryNot yet recruiting
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University of MichiganCompleted
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SciensanoEuropean CommissionNot yet recruitingCancerHungary, Greece, Belgium, Cyprus, Ireland, Italy, Lithuania, Portugal, Slovenia, Spain
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University of Cape TownKarolinska Institutet; University of California, San Francisco; Grand Challenges...Recruiting
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University Hospital MuensterPalliativnetz Muenster gGmbH; CompuGroup MedicalCompletedCancer | Chronic Obstructive Pulmonary Disease | Chronic Heart Failure | Palliative CareGermany