AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Success Rate without Active Assistant Help
研究概览
简要总结
A pragmatic trial will be conducted in two representative clinics in each of the three types of targeted settings. It will be run for 3 months in each clinic to complete data collection of up to 100 patients in SPGC and Optometry Clinics, 200 at GPGC and 200 in GOPC in total. All the subjects will conduct a DIY screening, physician consultation, survey with questionnaires and a phone interview three months after their baseline assessment. This study will assess automated screening in terms of success rate of the DIY system without active assistant help, accuracy, screening rate and detection rate, adherence to referral and experience of participants, as well as cost-effectiveness in real-world settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
- •have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
- •Provide written informed consent.
排除标准
- •individuals with physical disabilities that prevent the use of a fundus camera, or
- •individuals with speech impairments who are unable to complete telephone follow-ups.
结局指标
主要结局
Success Rate without Active Assistant Help
时间窗: 3 months
Success rate of using the DIY screening booth help will be determined by the number of successful screening runs without active assistant help divided by the total number of screening runs.
次要结局
- Assessment of Consumer Acceptability(3 months)
- Disease Detection Rates(3 months)
- Adherence to Referral(3 months)
- Technical Feasibility: Quality of Image Acquisition(3 months)
- Cost-effectiveness of DIY Screening(3 months)
- Assessment of Consumer Satisfaction(3 months)
- Technical Feasibility:The duration of Clinic Flow(3 months)
- Technical Feasibility:Reporting and Impact on Clinic Flow(3 months)
- Technical Feasibility: The type of technical error(3 months)
- Technical Feasibility: Number of Recorded Technical Errors(3 months)
- Technical Feasibility: Remedies for technical errors(3 months)
- Diagnostic Accuracy(3 months)