The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
Recruitment status was Active, not recruiting
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy|
- 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) ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|