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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628289
• Other study ID #: UW 08-134
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: June 21, 2012
• Start date: February 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4644
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Only if not competent to give informed consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Other:
• charging a co-payment for Diabetic Retinopathy screening
The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.
• free screening without charging a co-payment
The intervention is to provide free screening without charging a co-payment

Locations

Country	Name	City	State
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	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinopathy profile in the two groups	The extent of diabetic retinopathy in two groups were measured in the first year screening.	the first year	No
Secondary	Subjects' attendance of the screening	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	No
Secondary	Retinopathy profile in the two groups	The extent of diabetic retinopathy in two groups were measured in the second year screening.	the second year	No
Secondary	Subjects' attendance of the screening	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	No