The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong

June 21, 2012 updated by: The University of Hong Kong

Introduction: There is no debate that people with diabetes should be screened for the development of retinopathy which can threaten their sight. However, there is no routine screening for retinopathy in Hong Kong at present. Many overseas countries find that they miss a large proportion of their target population and, with reliance on co-payments for screening, as is the case with the limited opportunistic screening at present, the cost-effectiveness of any routine service in Hong Kong could be reduced as is predicted by Hart's inverse care law.

Aim: This study will determine the potential cost-effectiveness of screening for retinopathy in Hong Kong under a free system and one in which a co-payment is charged.

Methods: Primary care patients attending General Outpatient Clinics on Hong Kong Island for their routine diabetic care will randomly be offered screening either at no charge or with the normal co-payment of $65. Those who are willing and unwilling to be screened will be compared for their clinical, lifestyle and socioeconomic characteristics and those unwilling will be asked their reasons. The uptake of screening at no fee and with a payment will be compared as will the prevalence of retinopathy in the two fee groups. Subsequent screening at one year will be offered at the same fee and uptake again compared.

The principal analyses will (a) identify the characteristics of those willing to be screened and reasons for not being screened (b) the uptake of screening when a co-payment is charged compared to when it is free (c) whether there is a difference in the prevalence of retinopathy between the group willing to pay and those who accept free screening and (d) the uptake of re-screening in year 2.

The resulting cost-effectiveness model will use these data, the cost data collected during the study and overseas data on benefits of treatment to model the cost-effectiveness of screening for retinopathy in Hong Kong if it were to be offered free or with a co-payment. This information will be important to determine the most cost-effective means of implementing this preventative strategy to preserve sight and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4644

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Aberdeen General Outpatient Clinic,Hospital Authority
      • Hong Kong, China
        • Department of Community Medicine,The University of Hong Kong
      • Hong Kong, China
        • Eye Institute, Faculty of Medicine, The University of Hong Kong, Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All diabetic patients who attend the clinic during the study period.

Exclusion Criteria:

  • Only if not competent to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: free screening group
Subjects in this group receive free diabetic retinopathy screening.
Other: free screening without charging a co-payment
The intervention is to provide free screening without charging a co-payment
Other: Pay screening group
Subjects in this group receive diabetic retinopathy screening with charging a co-payment.
Other: charging a co-payment for Diabetic Retinopathy screening
The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinopathy profile in the two groups
Time Frame: the first year
The extent of diabetic retinopathy in two groups were measured in the first year screening.
the first year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects' attendance of the screening
Time Frame: the first year
Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the first year screening.
the first year
Retinopathy profile in the two groups
Time Frame: the second year
The extent of diabetic retinopathy in two groups were measured in the second year screening.
the second year
Subjects' attendance of the screening
Time Frame: the second year
Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the second year screening.
the second year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Sarah M McGhee, PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 21, 2012

First Posted (Estimate)

June 26, 2012

Study Record Updates

Last Update Posted (Estimate)

June 26, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 08-134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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