- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02866734
Diabetic Retinopathy Screening in Private Practice
The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong
Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic retinopathy (DR) is one of the most common complications of DM. Screening for DR is a cost-effective method to identify patients who are at risk of vision loss so that timely treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set up screening services (RAMP) in the government outpatient clinics and all DM patients attending these clinics will be screened at least once every two years and some every six months, according to their individual risks. However, those diabetic patients who attend the private sector for their primary care may not have access to this service.
Aim: This study from the University of Hong Kong aims to determine the characteristics of a sustainable approach to setting up an effective and quality-controlled screening service for DR in the private primary care sector of Hong Kong and to estimate the potential benefit to be gained in terms of impact on avoidable vision loss, costs of care and potential for further development of this model in chronic disease care.
Methods:A screening centre is being set up and a randomised study carried out in which screening will be offered at three different fee levels to subjects recruited by their general practitioner (GP). The following data will be collected (a) willingness to attend screening at the different fee levels (b) screening findings in terms of DR and other eye diseases (c) risk factors and other characteristics of those screened and unscreened. The information will allow us to estimate the level of fee which best combines effectiveness with sustainability in the longer term.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Department of Ophthalmology, The University of Hong Kong, Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed to have diabetic mellitus
- Able to give informed consent
Exclusion Criteria:
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Free screening group
Subjects in this group receive free diabetic retinopathy screening.
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The intervention provide Diabetic Retinopathy screening without charging a fee.
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Active Comparator: Pay screening group ($150)
Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.
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The intervention is charging HK$150 for the Diabetic Retinopathy screening.
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Active Comparator: Pay screening group ($300)
Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.
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The intervention is charging HK$300 for the Diabetic Retinopathy screening.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants with diabetes who are only under the care of a private GP, or also attend specialist service, and have had access to DR screening
Time Frame: one year
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one year
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Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care
Time Frame: one year
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one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Cheuk Hung Chan, MBBS, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12133951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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