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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01628289
First received: June 15, 2012
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Diabetic Retinopathy
Other: charging a co-payment for Diabetic Retinopathy screening
Other: free screening without charging a co-payment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Retinopathy profile in the two groups [ Time Frame: the first year ] [ Designated as safety issue: No ]
    The extent of diabetic retinopathy in two groups were measured in the first year screening.


Secondary Outcome Measures:
  • Subjects' attendance of the screening [ Time Frame: the first year ] [ Designated as safety issue: No ]
    Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the first year screening.

  • Retinopathy profile in the two groups [ Time Frame: the second year ] [ Designated as safety issue: No ]
    The extent of diabetic retinopathy in two groups were measured in the second year screening.

  • Subjects' attendance of the screening [ Time Frame: the second year ] [ Designated as safety issue: No ]
    Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the second year screening.


Enrollment: 4644
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Only if not competent to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628289

Locations
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, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Sarah M McGhee, PhD The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01628289     History of Changes
Other Study ID Numbers: UW 08-134
Study First Received: June 15, 2012
Last Updated: June 21, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
diabetic retinopathy
screening
co-payment
health service

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014