Diabetic Retinopathy Screening in Private Practice

NCT ID: NCT02866734

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-06-01

Brief Summary

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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

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Free screening group

Subjects in this group receive free diabetic retinopathy screening.

Group Type ACTIVE_COMPARATOR

Free screening group

Intervention Type OTHER

The intervention provide Diabetic Retinopathy screening without charging a fee.

Pay screening group ($150)

Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.

Group Type ACTIVE_COMPARATOR

Pay screening group ($150)

Intervention Type OTHER

The intervention is charging HK$150 for the Diabetic Retinopathy screening.

Pay screening group ($300)

Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.

Group Type ACTIVE_COMPARATOR

Pay screening group ($300)

Intervention Type OTHER

The intervention is charging HK$300 for the Diabetic Retinopathy screening.

Interventions

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Free screening group

The intervention provide Diabetic Retinopathy screening without charging a fee.

Intervention Type OTHER

Pay screening group ($150)

The intervention is charging HK$150 for the Diabetic Retinopathy screening.

Intervention Type OTHER

Pay screening group ($300)

The intervention is charging HK$300 for the Diabetic Retinopathy screening.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Cheuk Hung Chan, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Department of Ophthalmology, The University of Hong Kong, Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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12133951

Identifier Type: -

Identifier Source: org_study_id

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