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NCT01364129 Clinical Trial

The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:
The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01364129
Other study ID # NPAIHB O5-P-O5
Secondary ID 1-U-48-DP-002673
Status Completed
Phase N/A
First received April 27, 2011
Last updated March 7, 2016
Start date August 2006
Est. completion date June 2012

Study information
Verified date March 2016
Source Legacy Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 567
Est. completion date June 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Yellowhawk Tribal Health Center Pendleton Oregon
United States Hunter Health Clinic Wichita Kansas

Sponsors (3)
Lead Sponsor Collaborator
Legacy Health System Centers for Disease Control and Prevention, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 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) No
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