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The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01364129
Enrollment
567
Registered
2011-06-02
Start date
2006-08-31
Completion date
2012-06-30
Last updated
2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Diabetes, Diabetic Retinopathy Screening, Ophthalmic Telemedicine, Comparative Effectiveness Research

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.

Interventions

PROCEDUREOphthalmic 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.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Oregon Health and Science University
CollaboratorOTHER
Legacy Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants that Receive Annual Eye ExamBaseline; 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026