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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

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.


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Other: Free screening group Other: Pay screening group ($150) Other: Pay screening group ($300) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : December 13, 2017
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Free screening group
Subjects in this group receive free diabetic retinopathy screening.
Other: Free screening group
The intervention provide Diabetic Retinopathy screening without charging a fee.

Active Comparator: Pay screening group ($150)
Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.
Other: Pay screening group ($150)
The intervention is charging HK$150 for the Diabetic Retinopathy screening.

Active Comparator: Pay screening group ($300)
Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.
Other: Pay screening group ($300)
The intervention is charging HK$300 for the Diabetic Retinopathy screening.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866734


Locations
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Hong Kong
Department of Ophthalmology, The University of Hong Kong, Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Jonathan Cheuk Hung Chan, MBBS The University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02866734     History of Changes
Other Study ID Numbers: 12133951
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The University of Hong Kong:
Diabetic Retinopathy
Screening
Fee for screening
Private practice

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases