Clinical trial NCT02866734: Diabetic Retinopathy Screening in Private Practice
Official title: The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: Diabetic Retinopathy
Screening
Fee for screening
Private practice
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's
timeFrame: one year
Secondary outcomes:
measure: 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
timeFrame: one year
measure: Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care
timeFrame: one year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Ophthalmology, The University of Hong Kong, Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Jonathan Cheuk Hung Chan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: