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Diabetic Retinopathy Screening in Private Practice

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ClinicalTrials.gov Identifier: NCT02866734
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE July 27, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE September 1, 2016
Actual Primary Completion Date December 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02866734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diabetic Retinopathy Screening in Private Practice
Official Title  ICMJE The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Diabetic Retinopathy
Intervention  ICMJE
  • Other: Free screening group
    The intervention provide Diabetic Retinopathy screening without charging a fee.
  • Other: Pay screening group ($150)
    The intervention is charging HK$150 for the Diabetic Retinopathy screening.
  • Other: Pay screening group ($300)
    The intervention is charging HK$300 for the Diabetic Retinopathy screening.
Study Arms  ICMJE
  • Active Comparator: Free screening group
    Subjects in this group receive free diabetic retinopathy screening.
    Intervention: Other: Free screening group
  • Active Comparator: Pay screening group ($150)
    Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.
    Intervention: Other: Pay screening group ($150)
  • Active Comparator: Pay screening group ($300)
    Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.
    Intervention: Other: Pay screening group ($300)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2018)
238
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
1500
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date December 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed to have diabetic mellitus
  • Able to give informed consent

Exclusion Criteria:

  • Pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT02866734
Other Study ID Numbers  ICMJE 12133951
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Cheuk Hung Chan, MBBS The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP