Smartphone App for Taking Images of Conjunctivae
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|ClinicalTrials.gov Identifier: NCT03997487|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : July 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Trachoma||Other: TOFTEE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 8, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Children examined
All children examined for clinical signs of trachoma will be invited to participate to have photos of conjunctivae taken with the TOFTEE smartphone app and a DSLR camera.
Smartphone app for taking quality images of conjunctivae
- TOols For Trachoma Elimination Endgame (TOFTEE) app image quality [ Time Frame: 30 minutes ]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.
- Kappa score of TOFTEE image compared with field grading [ Time Frame: 5 minutes ]Concordance in diagnosis of trachoma between field grading and app image
- Kappa score of TOFTEE image compared with DSLR grading [ Time Frame: 5 minutes ]Concordance in diagnosis of trachoma between app image and DSLR image
- Kappa score of DSLR image compared with field grading [ Time Frame: 5 minutes ]Concordance in diagnosis of trachoma between field grading and DSLR image
- Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality [ Time Frame: 15 minutes ]Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics acceptable photo quality
- Acceptability and feasibility of TOFTEE app in communities [ Time Frame: 45 minutes ]Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of TOFTEE app in communities
- Acceptability and feasibility of TOFTEE app in Tropical Data system [ Time Frame: 45 minutes ]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
- Cost of TOFTEE app implementation [ Time Frame: 5 days ]Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of TOFTEE app implementation into the Tropical Data system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997487
|Contact: Emma Harding-Esch, PhDemail@example.com|
|Contact: Upendo Mwingira|
|Principal Investigator:||Emma Harding-Esch||LSHTM|