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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
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, Fee for screening, Private practice

Eligibility Criteria

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

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

First Posted
July 27, 2016
Last Updated
October 10, 2018
Sponsor
The University of Hong Kong
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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

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Diabetic Retinopathy Screening in Private Practice

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