Diabetic Retinopathy Screening in Private Practice

Not Applicable

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Other: Pay screening group ($300); Other: Pay screening group ($150); Other: Free screening group

• Registration Number: NCT02866734
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Study Start: 2016-09-01
• Primary Completion: 2017-12-13
• Study Completion: 2018-06-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• Patients diagnosed to have diabetic mellitus
• Able to give informed consent

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Exclusion Criteria

• Pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pay screening group ($300)	Pay screening group ($300)	Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.
Pay screening group ($150)	Pay screening group ($150)	Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.
Free screening group	Free screening group	Subjects in this group receive free diabetic retinopathy screening.

Primary Outcome Measures

Name	Time	Method
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's	one year

Secondary Outcome Measures

Name	Time	Method
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	one year
Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care	one year

Trial Locations

Locations (1)

Department of Ophthalmology, The University of Hong Kong, Hong Kong; 🇭🇰 Hong Kong, Hong Kong