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

Trachoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04002726
• Other study ID #: 2019-KEP-284 - 1
• Status: Terminated
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: July 12, 2019

Study information

• Verified date: May 2022
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Trachoma

Intervention

Other:
• Inter-grader agreement (IGA) app
A smartphone-based app with images of conjunctivae for trachoma grading training purposes.

Locations

Country	Name	City	State
Tanzania	Arusha region	Arusha

Sponsors (9)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, National Institute for Medical Research, Tanzania, Pan American Health Organization, RTI International, Sightsavers, University College London Hospitals, World Health Organization

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classroom IGA success	The proportion of participants successfully passing (kappa =0.7) the app-based IGA.	1 day
Primary	Classroom IGA success	The proportion of participants successfully passing (kappa =0.7) the slide-based IGA.	1 day
Primary	Field IGA success	The correlation between classroom IGA score and field IGA score	3 days
Primary	Field IGA success	The proportion of participants who successfully pass the classroom IGA test (kappa =0.7) who also successfully pass the field-based IGA test (kappa =0.7)	3 days
Secondary	Trainee characteristics	Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing classroom IGA test	5 days
Secondary	Trainee characteristics	Association (reported as proportions, unadjusted and adjusted odds ratios) between trainee characteristics and the probability of successfully passing the field IGA test	5 days
Secondary	Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based training.	Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based training.	45 minutes
Secondary	Acceptability and feasibility (common themes from focus group discussions) of app versus slide-based IGA testing.	Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of app versus slide-based IGA testing.	45 minutes
Secondary	Cost of app versus slide-based training	Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based training	5 days
Secondary	Cost of app versus slide-based IGA testing	Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of app versus slide-based IGA testing	5 days