The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01364129|
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : March 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Procedure: Ophthalmic Telemedicine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||567 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|United States, Kansas|
|Hunter Health Clinic|
|Wichita, Kansas, United States, 67214|
|United States, Oregon|
|Yellowhawk Tribal Health Center|
|Pendleton, Oregon, United States, 97801|
|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|