Diabetic Retinopathy Screening in Private Practice
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Free screening group
Pay screening group ($150)
Pay screening group ($300)
Sponsored by
About this trial
This is an interventional health services research trial for Diabetic Retinopathy focused on measuring Diabetic Retinopathy, Screening, Fee for screening, Private practice
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed to have diabetic mellitus
- Able to give informed consent
Exclusion Criteria:
- Pregnant women
Sites / Locations
- Department of Ophthalmology, The University of Hong Kong, Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Free screening group
Pay screening group ($150)
Pay screening group ($300)
Arm Description
Subjects in this group receive free diabetic retinopathy screening.
Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.
Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.
Outcomes
Primary Outcome Measures
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's
Secondary Outcome Measures
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
Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care
Full Information
NCT ID
NCT02866734
First Posted
July 27, 2016
Last Updated
October 10, 2018
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02866734
Brief Title
Diabetic Retinopathy Screening in Private Practice
Official Title
The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
June 1, 2018 (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: 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.
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, Fee for screening, Private practice
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Free screening group
Arm Type
Active Comparator
Arm Description
Subjects in this group receive free diabetic retinopathy screening.
Arm Title
Pay screening group ($150)
Arm Type
Active Comparator
Arm Description
Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.
Arm Title
Pay screening group ($300)
Arm Type
Active Comparator
Arm Description
Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.
Intervention Type
Other
Intervention Name(s)
Free screening group
Intervention Description
The intervention provide Diabetic Retinopathy screening without charging a fee.
Intervention Type
Other
Intervention Name(s)
Pay screening group ($150)
Intervention Description
The intervention is charging HK$150 for the Diabetic Retinopathy screening.
Intervention Type
Other
Intervention Name(s)
Pay screening group ($300)
Intervention Description
The intervention is charging HK$300 for the Diabetic Retinopathy screening.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed to have diabetic mellitus
Able to give informed consent
Exclusion Criteria:
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Cheuk Hung Chan, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, The University of Hong Kong, Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diabetic Retinopathy Screening in Private Practice
We'll reach out to this number within 24 hrs