NCT01364129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
567

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

5.3 years

First QC Date

April 27, 2011

Last Update Submit

March 7, 2016

Conditions

Diabetic Retinopathy

Keywords

DiabetesDiabetic Retinopathy ScreeningOphthalmic TelemedicineComparative Effectiveness Research

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Telemedicine

EXPERIMENTAL

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

Traditional Surveillance

NO INTERVENTION

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

Interventions

Ophthalmic TelemedicinePROCEDURE

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.

Telemedicine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hunter Health Clinic

Wichita, Kansas, 67214, United States

Location

Yellowhawk Tribal Health Center

Pendleton, Oregon, 97801, United States

Location

Related Publications (2)

  • 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.

    PMID: 27328169DERIVED

  • 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.

    PMID: 25741666DERIVED

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Steven L Mansberger, MD, MPH

    Legacy Health System, Devers Eye Institute

    PRINCIPAL INVESTIGATOR

  • Thomas M Becker, MD, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH

Study Record Dates

First Submitted

April 27, 2011

First Posted

June 2, 2011

Study Start

August 1, 2006

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

US(2)