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临床试验/NCT02866734
NCT02866734已完成不适用

The Feasibility of Screening for Diabetic Retinopathy in Private Practice Hong Kong

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
238
试验地点
1
主要终点
The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Pregnant women

研究组 & 干预措施

Free screening group

Active Comparator

Subjects in this group receive free diabetic retinopathy screening.

干预措施: Free screening group (Other)

Pay screening group ($150)

Active Comparator

Subjects in this group receiving diabetic retinopathy screening will be charged HK$150.

干预措施: Pay screening group ($150) (Other)

Pay screening group ($300)

Active Comparator

Subjects in this group receiving diabetic retinopathy screening will be charged HK$300.

干预措施: Pay screening group ($300) (Other)

结局指标

主要结局

The overall, & at different fee level, uptake (as a percentage of participants) of screening from those at-risk patients who attend private GP's

时间窗: one year

次要结局

  • 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(one year)
  • Prevalence of DR (overall, and for sight-threatening diabetic retinopathy) among diabetic patients in private primary care(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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