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Uptake of Telemedicine System Trial in Rual Canton

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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

Tracking Information
First Submitted Date April 11, 2013
First Posted Date April 15, 2013
Last Update Posted Date May 22, 2013
Study Start Date April 2013
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2013)
  • 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)
  • cost-effectiveness [ Time Frame: 2 years ]
    Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01832077 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 12, 2013)
  • 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)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Uptake of Telemedicine System Trial in Rual Canton
Official Title The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton
Brief Summary To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment of Diabetes retinopathy and Diabetes macular edema.
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 Type Observational [Patient Registry]
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population age > 40y, diagnosed (Diabetes Retinapathy)DR, 10% normal patients
Condition
  • Diabetes Retinopathy
  • Diabetes Macular Edema
Intervention
  • Device: 90 D
    rural doctors exam eye fundus by 90 D
  • Device: fundus camera and grader
    taking fundus pictures and graded by graders in ZOC
Study Groups/Cohorts
  • rural doctor
    examine patient's fundus by 90D fundus pre-set lens
    Intervention: Device: 90 D
  • grader
    grade fundus pictures in ZOC
    Intervention: Device: fundus camera and grader
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 12, 2013)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01832077
Other Study ID Numbers ZOC-WDF-Telemedicine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Congdon Nathan, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators
  • Orbis
  • The World Diabetes Foundation
Investigators
Principal Investigator: Nathan Congdong, MD,MPH Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date May 2013