NCT01628289

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,644

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

June 15, 2012

Last Update Submit

June 21, 2012

Conditions

Keywords

diabetic retinopathyscreeningco-paymenthealth service

Outcome Measures

Primary Outcomes (1)

  • Retinopathy profile in the two groups

    The extent of diabetic retinopathy in two groups were measured in the first year screening.

    the first year

Secondary Outcomes (3)

  • Subjects' attendance of the screening

    the first year

  • Retinopathy profile in the two groups

    the second year

  • Subjects' attendance of the screening

    the second year

Study Arms (2)

free screening group

OTHER

Subjects in this group receive free diabetic retinopathy screening.

Other: free screening without charging a co-payment

Pay screening group

OTHER

Subjects in this group receive diabetic retinopathy screening with charging a co-payment.

Other: charging a co-payment for Diabetic Retinopathy screening

Interventions

The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.

Pay screening group

The intervention is to provide free screening without charging a co-payment

free screening group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Only if not competent to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aberdeen General Outpatient Clinic,Hospital Authority

Hong Kong, China

Location

Department of Community Medicine,The University of Hong Kong

Hong Kong, China

Location

Eye Institute, Faculty of Medicine, The University of Hong Kong, Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Sarah M McGhee, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 26, 2012

Study Start

February 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations