Diabetic RetinopathyNCT02866734
Diabetic Retinopathy Screening in Private Practice
A study testing Free screening group, Pay screening group ($150) and Pay screening group ($300) in people with Diabetic Retinopathy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic retinopathy (DR) is one of the most common complications of DM. Screening for DR is a cost-effective method to identify patients who are at risk of vision loss so that timely treatment can be provided to patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Free screening group, Pay screening group ($150) and Pay screening group ($300)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2016to 1 Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed to have diabetic mellitus
- Able to give informed consent
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Ophthalmology, The University of Hong Kong, Hong Kong
Hong Kong
About this study
Official title: The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong
Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic retinopathy (DR) is one of the most common complications of DM. Screening for DR is a cost-effective method to identify patients who are at risk of vision loss so that timely treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set up screening services (RAMP) in the government outpatient clinics and all DM patients attending these clinics will be screened at least once every two years and some every six months, according to their individual risks. However, those diabetic patients who attend the private sector for their primary care may not have access to this service.
Aim: This study from the University of Hong Kong aims to determine the characteristics of a sustainable approach to setting up an effective and quality-controlled screening service for DR in the private primary care sector of Hong Kong and to estimate the potential benefit to be gained in terms of impact on avoidable vision loss, costs of care and potential for further development of this model in chronic disease care.
Methods:A screening centre is being set up and a randomised study carried out in which screening will be offered at three different fee levels to subjects recruited by their general practitioner (GP). The following data will be collected (a) willingness to attend screening at the different fee levels (b) screening findings in terms of DR and other eye diseases (c) risk factors and other characteristics of those screened and unscreened. The information will allow us to estimate the level of fee which best combines effectiveness with sustainability in the longer term.
- Conditions
- Diabetic Retinopathy
- Being tested
- Free screening group, Pay screening group ($150), Pay screening group ($300)
- Keywords
- Diabetic Retinopathy, Screening, Fee for screening, Private practice
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free screening groupOther
The intervention provide Diabetic Retinopathy screening without charging a fee.
Pay screening group ($150)Other
The intervention is charging HK$150 for the Diabetic Retinopathy screening.
Pay screening group ($300)Other
The intervention is charging HK$300 for the Diabetic Retinopathy screening.
| Study group | Role | What they receive |
|---|---|---|
| Free screening group | Active comparator | Subjects in this group receive free diabetic retinopathy screening. Receives: Other: Free screening group |
| Pay screening group ($150) | Active comparator | Subjects in this group receiving diabetic retinopathy screening will be charged HK$150. Receives: Other: Pay screening group ($150) |
| Pay screening group ($300) | Active comparator | Subjects in this group receiving diabetic retinopathy screening will be charged HK$300. Receives: Other: Pay screening group ($300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's
Measured: one year
Secondary outcomes (2)
Percentage of participants with diabetes who are only under the care of a private GP, or also attend specialist service, and have had access to DR screening
Measured: one year
Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start1 Sep 2016
- Primary completion13 Dec 2017
- Study completion1 Jun 2018
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
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Cheuk Hung Chan, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866734
- Sponsor's protocol ID
- 12133951
- Status last verified
- Oct 2018
- First submitted
- 27 Jul 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong
- ClinicalTrials.gov ID
- NCT02866734
- Acronym / sponsor ID
- 12133951
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, Screening, Fee for screening, Private practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 15 Aug 2016 (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: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic retinopathy (DR) is one of the most common complications of DM. Screening for DR is a cost-effective method to identify patients who are at risk of vision loss so that timely treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set up screening services (RAMP) in the government outpatient clinics and all DM patients attending these clinics will be screened at least once every two years and some every six months, according to their individual risks. However, those diabetic patients who attend the private sector for their primary care may not have access to this service.
Aim: This study from the University of Hong Kong aims to determine the characteristics of a sustainable approach to setting up an effective and quality-controlled screening service for DR in the private primary care sector of Hong Kong and to estimate the potential benefit to be gained in terms of impact on avoidable vision loss, costs of care and potential for further development of this model in chronic disease care.
Methods:A screening centre is being set up and a randomised study carried out in which screening will be offered at three different fee levels to subjects recruited by their general practitioner (GP). The following data will be collected (a) willingness to attend screening at the different fee levels (b) screening findings in terms of DR and other eye diseases (c) risk factors and other characteristics of those screened and unscreened. The information will allow us to estimate the level of fee which best combines effectiveness with sustainability in the longer term.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Free screening group | Active comparator | Other: Free screening groupSubjects in this group receive free diabetic retinopathy screening. |
| Pay screening group ($150) | Active comparator | Other: Pay screening group ($150)Subjects in this group receiving diabetic retinopathy screening will be charged HK$150. |
| Pay screening group ($300) | Active comparator | Other: Pay screening group ($300)Subjects in this group receiving diabetic retinopathy screening will be charged HK$300. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed to have diabetic mellitus
- Able to give informed consent
Key exclusion criteria (1 listed)
- Pregnant women
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 |
|---|---|---|
| Free screening groupThe intervention provide Diabetic Retinopathy screening without charging a fee. | Other | Free screening group |
| Pay screening group ($150)The intervention is charging HK$150 for the Diabetic Retinopathy screening. | Other | Pay screening group ($150) |
| Pay screening group ($300)The intervention is charging HK$300 for the Diabetic Retinopathy screening. | Other | Pay screening group ($300) |
Primary outcome
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's
Time frame: one year
2 secondary outcomes
Percentage of participants with diabetes who are only under the care of a private GP, or also attend specialist service, and have had access to DR screening
Time frame: one year
Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care
Time frame: one 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 11 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Jonathan Cheuk Hung Chan, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free screening group, Pay screening group ($150) and Pay screening group ($300) in people with Diabetic Retinopathy, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's (time frame: one 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 11 Oct 2018.