The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

NCT ID: NCT01364129

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

567 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Telemedicine

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.

Group Type EXPERIMENTAL

Ophthalmic Telemedicine

Intervention Type PROCEDURE

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.

Traditional Surveillance

Participants in this group are encouraged to see an eye care provider each year for a diabetic eye exam.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

Legacy Health System

OTHER

Sponsor Role lead

Responsible Party

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Steven L. Mansberger

MD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven L Mansberger, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Legacy Health System, Devers Eye Institute

Thomas M Becker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Hunter Health Clinic

Wichita, Kansas, United States

Site Status

Yellowhawk Tribal Health Center

Pendleton, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27328169 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25741666 (View on PubMed)

Other Identifiers

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1-U-48-DP-002673

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NPAIHB O5-P-O5

Identifier Type: -

Identifier Source: org_study_id

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