Smartphone App for Taking Images of Conjunctivae

Trachoma Clinical Trial

Official title:

Developing and Evaluating Trachoma Diagnosis Training Tools in Preparation for the Trachoma Elimination Endgame: Development of a Smartphone Application to Capture Quality Images of Everted Eye Lids and Assessment of Its Acceptability and Feasibility

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03997487
• Other study ID #: 2019-KEP-284 - 2
• 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 develop a smartphone application and assess its acceptability and feasibility. Fieldwork will take place during routine Tropical Data trainings and population-based prevalence surveys supported by Tropical Data. Healthy adult volunteers in London will have photos of their conjunctivae taken to develop the app initially, with iterative improvements to the app based on image quality achieved. For fieldwork, images of the conjunctivae of children will be have photos of their conjunctivae taken with a digital single lens reflex (DSLR) camera and the newly developed smartphone app. Grading of the photos will be compared with field grading, to compare grading agreement, to assess utility for supervision, quality assurance and training purposes.

Description:

The investigators want to see whether it would be possible to take photos using Android smartphones, routinely used in trachoma surveys for collecting data, for quality assurance, supervision and training purposes. The investigators will develop an app in the United Kingdom (UK) by taking photos of the conjunctivae of healthy adult volunteers to iteratively improve the quality of images based on the image metadata and review by trachoma experts. The app will then be field tested, and trachoma grading based on the app photos, DSLR photos, and clinical grading, compared. Any management (treatment) will be based on routine clinical diagnosis only - the images are for research purposes only. The investigators will also ask participants for their views on acceptability of having photos of conjunctivae taken with the phone, and conduct a cost-consequences analysis of potential implementation of the app in routine trachoma surveys. Objectives and approach: 2.1 To develop a mobile phone application to capture images of everted eyelids (conjunctivae) of children being examined as part of the Tropical Data field inter-grader agreement (IGA) test, or sampled as part of trachoma prevalence surveys. 2.2 To evaluate the quality of the mobile phone application images compared with field grading and DSLR images. 2.3 To assess the acceptability and feasibility of a mobile phone application for photographing everted eyelids (conjunctivae) from children being examined as part of the Tropical Data IGA test, or sampled as part of trachoma prevalence surveys. 2.4 To conduct a cost-consequences analysis of setting up an infrastructure for capturing and transmitting images in order to make the system economically viable.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

Objectives 2.1 and 2.2:

• For the London-based app development, any eligible healthy adult who provides written informed consent will be eligible.
• For the field-based app development, any child aged 1-9 years being examined as part of the Tropical Data IGA test, or sampled as part of trachoma prevalence surveys, and for whom written informed consent has been provided by a guardian, will be eligible.

Objective 2.3:

• All Tropical Data trainers and trainees attending the Tropical Data (initial and refresher) training events and who provide written informed consent, will be eligible.
• Community leaders and children's guardians who provide written informed consent will be eligible.

Exclusion Criteria:

• For each of the objectives, if the inclusion criteria are not fulfilled, the participant will not be eligible to participate.

Related Conditions & MeSH terms

• Trachoma

Intervention

Other:
• TOFTEE
Smartphone app for taking quality images of conjunctivae

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	TOols For Trachoma Elimination Endgame (TOFTEE) app image quality	Photo quality will be assessed by trachoma grading experts. The technical parameters such as lighting, resolution, focus, etc. will be assessed using objective software or extracted from the photograph metadata.	30 minutes
Primary	Kappa score of TOFTEE image compared with field grading	Concordance in diagnosis of trachoma between field grading and app image	5 minutes
Primary	Kappa score of TOFTEE image compared with DSLR grading	Concordance in diagnosis of trachoma between app image and DSLR image	5 minutes
Primary	Kappa score of DSLR image compared with field grading	Concordance in diagnosis of trachoma between field grading and DSLR image	5 minutes
Secondary	Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality	Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics acceptable photo quality	15 minutes
Secondary	Acceptability and feasibility of TOFTEE app in communities	Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of TOFTEE app in communities	45 minutes
Secondary	Acceptability and feasibility of TOFTEE app in Tropical Data system	Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of TOFTEE app as part of the Tropical Data system	45 minutes
Secondary	Cost of TOFTEE app implementation	Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of TOFTEE app implementation into the Tropical Data system	5 days