Diabetic RetinopathyNCT01628289
The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong
A study testing charging a co-payment for Diabetic Retinopathy screening and free screening without charging a co-payment in people with Diabetic Retinopathy, run by The University of Hong Kong at 3 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- charging a co-payment for Diabetic Retinopathy screening and free screening without charging a co-payment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,644 participants
- Where
- 3 sitesChina
- Study dates
- Feb 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All diabetic patients who attend the clinic during the study period.
Who cannot join
- Only if not competent to give informed consent
Trial locations and contacts
3 sites in 1 country.
China3 sites
Aberdeen General Outpatient Clinic,Hospital Authority
Hong Kong
Department of Community Medicine,The University of Hong Kong
Hong Kong
Eye Institute, Faculty of Medicine, The University of Hong Kong, Hong Kong
Hong Kong
About this study
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.
Read more
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.
- Conditions
- Diabetic Retinopathy
- Being tested
- charging a co-payment for Diabetic Retinopathy screening, free screening without charging a co-payment
- Keywords
- diabetic retinopathy, screening, co-payment, health service
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
charging a co-payment for Diabetic Retinopathy screeningOther
The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.
free screening without charging a co-paymentOther
The intervention is to provide free screening without charging a co-payment
| Study group | Role | What they receive |
|---|---|---|
| free screening group | Other | Subjects in this group receive free diabetic retinopathy screening. Receives: 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. Receives: Other: charging a co-payment for Diabetic Retinopathy screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinopathy profile in the two groups
The extent of diabetic retinopathy in two groups were measured in the first year screening.
Measured: the first year
Secondary outcomes (3)
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.
Measured: the first year
Retinopathy profile in the two groups
The extent of diabetic retinopathy in two groups were measured in the second year screening.
Measured: the second year
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.
Measured: the second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah M McGhee, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628289
- Sponsor's protocol ID
- UW 08-134
- Status last verified
- Jun 2012
- First submitted
- 15 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong
- ClinicalTrials.gov ID
- NCT01628289
- Acronym / sponsor ID
- UW 08-134
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, screening, co-payment, health service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,644 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| free screening group | Other | Other: free screening without charging a co-paymentSubjects in this group receive free diabetic retinopathy screening. |
| Pay screening group | Other | Other: charging a co-payment for Diabetic Retinopathy screeningSubjects in this group receive diabetic retinopathy screening with charging a co-payment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All diabetic patients who attend the clinic during the study period.
Key exclusion criteria (1 listed)
- Only if not competent to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| charging a co-payment for Diabetic Retinopathy screeningThe intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening. | Other | Pay screening group |
| free screening without charging a co-paymentThe intervention is to provide free screening without charging a co-payment | Other | free screening group |
Primary outcome
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.
3 secondary outcomes
Subjects' attendance of the screening
Time frame: the first year
Retinopathy profile in the two groups
Time frame: the second year
Subjects' attendance of the screening
Time frame: the second year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah M McGhee, PhD principal investigator
The University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing charging a co-payment for Diabetic Retinopathy screening and free screening without charging a co-payment in people with Diabetic Retinopathy, run by The University of Hong Kong at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinopathy profile in the two groups (time frame: the first year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.