Uptake of Telemedicine System Trial in Rual Canton

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT01832077

Collaborator

Orbis (Other), The World Diabetes Foundation (Other)

5,000

Enrollment

Location

27.9

Actual Duration (Months)

179

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment of Diabetes retinopathy and Diabetes macular edema.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Retinopathy Diabetes Macular Edema	Device: 90 D Device: fundus camera and grader

Detailed Description

Telemedicine system mainly contains a comprehensive eye examination electric-records (E-record), which can transfer the fundus pictures from rural hospitals to professional Graders (golden standard for a diagnose of Diabetes Retinopathy (DR) and Diabetes Macular Edema(DME)). In Zhongshan Ophthalmic Center (ZOC). By this system, the investigators can evaluate the capacity of rural eye doctors about the diagnosis of DR/DME, and give proper suggestions for the treatment and revisit plan.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

5000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
rural doctor examine patient's fundus by 90D fundus pre-set lens	Device: 90 D rural doctors exam eye fundus by 90 D
grader grade fundus pictures in ZOC	Device: fundus camera and grader taking fundus pictures and graded by graders in ZOC

Arm

Intervention/Treatment

rural doctor

examine patient's fundus by 90D fundus pre-set lens

Device: 90 D

rural doctors exam eye fundus by 90 D

grader

grade fundus pictures in ZOC

Device: fundus camera and grader

taking fundus pictures and graded by graders in ZOC

Outcome Measures

Primary Outcome Measures

Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading [2 years after the telemedicine begin to use]
To compare the sensitivity, specificity and positive and negative predictive value for a diagnosis of DR/DME , a diagnosis of DR/DME requiring treatment, of trained rural doctors and an automated grading system, as compared to trained graders using photographs (the gold standard)
cost-effectiveness [2 years]
Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)

Secondary Outcome Measures

Frequency of comprehensive eye examination taken by rural doctors [2 years]
Frequency with which trained rural doctors continue to implement suggested examinations (IOP, gonioscopy, pupil exam, dilated examination)
comprehensive eye examination rate among patients in rural hospitals [2 years]
Frequency with which patients get comprehensive eye examinations in rural hospitals, and its influencing factors.
the usage rate of Electric-Record [2 years]
to evaluate the usage rate of E-record by rural doctors when they see patients in the eye clinic, and its influencing factors.
Cost-effectiveness of van [2 years]
compare the cost-effectiveness of van for laser treatment to DR/DME patients with the transfer treatment in ZOC

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age > 40y, diagnosed (Diabetes Retinopathy) DR,10% normal patients

Exclusion Criteria:

unconsciousness, history of diabetic ketoacidosis, cardiac insufficiency, Severe atrioventricular block, hepatic insufficiency , allergic to mydriatic