Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Uptake of Telemedicine System Trial in Rual Canton

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01832077
Recruitment Status : Unknown
Verified May 2013 by Congdon Nathan, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : April 15, 2013
Last Update Posted : May 22, 2013
Sponsor:
Collaborators:
Orbis
The World Diabetes Foundation
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

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
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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton
Study Start Date : April 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading [ Time Frame: 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)

  2. cost-effectiveness [ Time Frame: 2 years ]
    Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)


Secondary Outcome Measures :
  1. Frequency of comprehensive eye examination taken by rural doctors [ Time Frame: 2 years ]
    Frequency with which trained rural doctors continue to implement suggested examinations (IOP, gonioscopy, pupil exam, dilated examination)

  2. comprehensive eye examination rate among patients in rural hospitals [ Time Frame: 2 years ]
    Frequency with which patients get comprehensive eye examinations in rural hospitals, and its influencing factors.

  3. the usage rate of Electric-Record [ Time Frame: 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.

  4. Cost-effectiveness of van [ Time Frame: 2 years ]
    compare the cost-effectiveness of van for laser treatment to DR/DME patients with the transfer treatment in ZOC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
age > 40y, diagnosed (Diabetes Retinapathy)DR, 10% normal patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832077


Locations
Layout table for location information
China, Guangdong
Zhongshan Ophthalmic Center, No.54, Xianlienan Road
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Orbis
The World Diabetes Foundation
Investigators
Layout table for investigator information
Principal Investigator: Nathan Congdong, MD,MPH Zhongshan Ophthalmic Center, Sun Yat-sen University

Additional Information:

Layout table for additonal information
Responsible Party: Congdon Nathan, vice director,Blindness Prevention and Treatment Department, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01832077     History of Changes
Other Study ID Numbers: ZOC-WDF-Telemedicine
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013
Keywords provided by Congdon Nathan, Sun Yat-sen University:
sensibility
specificity
positive predictive value
negative predictive value
Cost-effectiveness
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Retinal Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Eye Diseases