Clinical trial NCT03997487: Smartphone App for Taking Images of Conjunctivae
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trachoma
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
name: Federal Minstry of Health of Ethiopia
name: Jos University Teaching Hospital
name: University College London Hospitals
name: RTI International
name: Sightsavers
name: World Health Organization
name: Pan American Health Organization
First posted: 2019-06-25
Enrollment: 125
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: TOols For Trachoma Elimination Endgame (TOFTEE) app image quality
timeFrame: 30 minutes
measure: Kappa score of TOFTEE image compared with field grading
timeFrame: 5 minutes
measure: Kappa score of TOFTEE image compared with DSLR grading
timeFrame: 5 minutes
measure: Kappa score of DSLR image compared with field grading
timeFrame: 5 minutes
Secondary outcomes:
measure: Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality
timeFrame: 15 minutes
measure: Acceptability and feasibility of TOFTEE app in communities
timeFrame: 45 minutes
measure: Acceptability and feasibility of TOFTEE app in Tropical Data system
timeFrame: 45 minutes
measure: Cost of TOFTEE app implementation
timeFrame: 5 days
Other outcomes:
Locations:
city: Arusha
country: Tanzania
facility: Arusha region
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Emma Harding-Esch
role: PRINCIPAL_INVESTIGATOR
References: