Developing and Evaluating Trachoma Diagnosis Training Tools in Preparation for the Trachoma Elimination Endgame: Investigating the Effectiveness, Acceptability and Feasibility of an App-based Versus Slide-based IGA Test for Trachoma Graders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Classroom IGA success
研究概览
简要总结
Trachomatous inflammation-follicular (TF) is diagnosed by looking for clinical signs of infection of everted eyelids (conjunctivae) of children.
The overall objective of this project is to investigate the effectiveness, acceptability and feasibility of an app-based versus slide-based IGA for trachoma graders.
Fieldwork will take place during routine Tropical Data trainings. A non-inferiority randomised controlled trial design will be employed, with grader trainees randomised to app- or slide-based training, and then to app- or slide-based IGA testing. The training and IGA testing method will be compared with field IGA test score to determine which method best predicts passing the field IGA test.
详细描述
Trachoma graders are currently trained using either slide- or app-based testing systems. The investigators want to formally assess whether the app-based training and testing system leads to better field-based diagnosis than the slide-based training and testing system. The investigators will also ask participants for their views on acceptability of the two systems and conduct a cost-consequences analysis of the two systems.
Objectives and approach:
1.1 To compare the two classroom IGA tests (app-based and slides-based) in terms of their ability to predict trainee success in the field IGA test.
1.2 To assess whether the kappa score threshold for the classroom IGA tests is appropriate.
1.3 To conduct a cost-consequences analysis of the training systems in order to effectively target the use of an app-based assessment and training system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •All trainers and trainee graders who attend selected Tropical Data training events will be eligible for inclusion in the study.
排除标准
- •Individuals who do not provide consent are not eligible for inclusion in the study.
研究组 & 干预措施
Group Aa
Allocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.
干预措施: Inter-grader agreement (IGA) app (Other)
Group As
Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.
干预措施: Inter-grader agreement (IGA) app (Other)
Group Sa
Allocated to do the slide-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.
干预措施: Inter-grader agreement (IGA) app (Other)
Group Ss
Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.
干预措施: Inter-grader agreement (IGA) app (Other)
结局指标
主要结局
Classroom IGA success
时间窗: 1 day
The proportion of participants successfully passing (kappa ≥0.7) the app-based IGA.
Field IGA success
时间窗: 3 days
The correlation between classroom IGA score and field IGA score
次要结局
- Trainee characteristics(5 days)
- Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.(45 minutes)
- Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.(45 minutes)
- Cost of app versus slide-based training(5 days)
- Cost of app versus slide-based IGA testing(5 days)