- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02866734
Diabetic Retinopathy Screening in Private Practice
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Hong Kong, Hong Kong
- Department of Ophthalmology, The University of Hong Kong, Hong Kong
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients diagnosed to have diabetic mellitus
- Able to give informed consent
Exclusion Criteria:
- Pregnant women
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Free screening group
Subjects in this group receive free diabetic retinopathy screening.
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The intervention provide Diabetic Retinopathy screening without charging a fee.
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Aktiv komparator: Pay screening group ($150)
Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.
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The intervention is charging HK$150 for the Diabetic Retinopathy screening.
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Aktiv komparator: Pay screening group ($300)
Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.
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The intervention is charging HK$300 for the Diabetic Retinopathy screening.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's
Tidsram: one year
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one year
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
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
Tidsram: one year
|
one year
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Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care
Tidsram: one year
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one year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jonathan Cheuk Hung Chan, MBBS, The University of Hong Kong
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12133951
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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