search
Back to results

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

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
charging a co-payment for Diabetic Retinopathy screening
free screening without charging a co-payment
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, screening, co-payment, health service

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Only if not competent to give informed consent

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

free screening group

Pay screening group

Arm Description

Subjects in this group receive free diabetic retinopathy screening.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Retinopathy profile in the two groups
The extent of diabetic retinopathy in two groups were measured in the second year screening.
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.

Full Information

First Posted
June 15, 2012
Last Updated
June 21, 2012
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT01628289
Brief Title
The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong
Official Title
The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
diabetic retinopathy, screening, co-payment, health service

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4644 (Actual)

8. Arms, Groups, and Interventions

Arm Title
free screening group
Arm Type
Other
Arm Description
Subjects in this group receive free diabetic retinopathy screening.
Arm Title
Pay screening group
Arm Type
Other
Arm Description
Subjects in this group receive diabetic retinopathy screening with charging a co-payment.
Intervention Type
Other
Intervention Name(s)
charging a co-payment for Diabetic Retinopathy screening
Intervention Description
The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.
Intervention Type
Other
Intervention Name(s)
free screening without charging a co-payment
Intervention Description
The intervention is to provide free screening without charging a co-payment
Primary Outcome Measure Information:
Title
Retinopathy profile in the two groups
Description
The extent of diabetic retinopathy in two groups were measured in the first year screening.
Time Frame
the first year
Secondary Outcome Measure Information:
Title
Subjects' attendance of the screening
Description
Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the first year screening.
Time Frame
the first year
Title
Retinopathy profile in the two groups
Description
The extent of diabetic retinopathy in two groups were measured in the second year screening.
Time Frame
the second year
Title
Subjects' attendance of the screening
Description
Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the second year screening.
Time Frame
the second year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All diabetic patients who attend the clinic during the study period. Exclusion Criteria: Only if not competent to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah M McGhee, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aberdeen General Outpatient Clinic,Hospital Authority
City
Hong Kong
Country
China
Facility Name
Department of Community Medicine,The University of Hong Kong
City
Hong Kong
Country
China
Facility Name
Eye Institute, Faculty of Medicine, The University of Hong Kong, Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs