App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders

London School of Hygiene and Tropical Medicine

Status: Terminated

Conditions: Trachoma

Treatments: Other: Inter-grader agreement (IGA) app

Study type: Interventional

Funder types: Other

Identifiers

NCT04002726

2019-KEP-284 - 1

Details and patient eligibility

About

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.

Full description

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.

1.4 To investigate whether grader trainee characteristics have an impact on trainee performance in the IGA tests.

1.5 To obtain feedback on the app-based system's usability and acceptability. 1.6 To compare the two classroom IGA training methods (app-based and slides-based) in terms of classroom IGA test (app-based and slides-based) outcome and field IGA test outcome.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All trainers and trainee graders who attend selected Tropical Data training events will be eligible for inclusion in the study.

Exclusion criteria

• Individuals who do not provide consent are not eligible for inclusion in the study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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32 participants in 4 patient groups

Group Aa

Active Comparator group

Description:

Allocated to do the app-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.

Treatment:

Other: Inter-grader agreement (IGA) app

Group As

Active Comparator group

Description:

Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.

Treatment:

Other: Inter-grader agreement (IGA) app

Group Sa

Active Comparator group

Description:

Allocated to do the slide-based training. Allocated to do the app-based classroom IGA test first, and the slide-based test second.

Treatment:

Other: Inter-grader agreement (IGA) app

Group Ss

Active Comparator group

Description:

Allocated to do the app-based training. Allocated to do the slide-based classroom IGA test first, and the app-based test second.

Treatment:

Other: Inter-grader agreement (IGA) app