Back to resultsThe Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ophthalmic Telemedicine
Sponsored by
About this trial
This is an interventional screening trial for Diabetic Retinopathy focused on measuring Diabetes, Diabetic Retinopathy Screening, Ophthalmic Telemedicine, Comparative Effectiveness Research
Eligibility Criteria
Inclusion Criteria:
- diabetic, at least 18 years old, patient at a participating health clinic
Sites / Locations
- Hunter Health Clinic
- Yellowhawk Tribal Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telemedicine
Traditional Surveillance
Arm Description
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 in this group are encouraged to see an eye care provider each year for a diabetic eye exam.
Outcomes
Primary Outcome Measures
Proportion of Participants that Receive Annual Eye Exam
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01364129
First Posted
April 27, 2011
Last Updated
March 7, 2016
Sponsor
Legacy Health System
Collaborators
Centers for Disease Control and Prevention, Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01364129
Brief Title
The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
Official Title
The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System
Collaborators
Centers for Disease Control and Prevention, Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Diabetes, Diabetic Retinopathy Screening, Ophthalmic Telemedicine, Comparative Effectiveness Research
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
567 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Surveillance
Arm Type
No Intervention
Arm Description
Participants in this group are encouraged to see an eye care provider each year for a diabetic eye exam.
Intervention Type
Procedure
Intervention Name(s)
Ophthalmic Telemedicine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Participants that Receive Annual Eye Exam
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diabetic, at least 18 years old, patient at a participating health clinic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Mansberger, MD, MPH
Organizational Affiliation
Legacy Health System, Devers Eye Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas M Becker, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Health Clinic
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Yellowhawk Tribal Health Center
City
Pendleton
State/Province
Oregon
ZIP/Postal Code
97801
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27328169
Citation
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.
Results Reference
derived
PubMed Identifier
25741666
Citation
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.
Results Reference
derived
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The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
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