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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
Sponsor:
Collaborators:
National Institute for Medical Research, Tanzania
Federal Minstry of Health of Ethiopia
Jos University Teaching Hospital
University College London, UK.
RTI International
Sightsavers
World Health Organization
Pan American Health Organization
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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.


Condition or disease Intervention/treatment Phase
Trachoma Other: TOFTEE Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: TOFTEE
Smartphone app for taking quality images of conjunctivae




Primary Outcome Measures :
  1. 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.

  2. Kappa score of TOFTEE image compared with field grading [ Time Frame: 5 minutes ]
    Concordance in diagnosis of trachoma between field grading and app image

  3. Kappa score of TOFTEE image compared with DSLR grading [ Time Frame: 5 minutes ]
    Concordance in diagnosis of trachoma between app image and DSLR image

  4. Kappa score of DSLR image compared with field grading [ Time Frame: 5 minutes ]
    Concordance in diagnosis of trachoma between field grading and DSLR image


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Emma Harding-Esch, PhD +442076127982 emma.harding-esch@lshtm.ac.uk

Locations
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Tanzania
Arusha region Recruiting
Arusha, Tanzania
Contact: Upendo Mwingira         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
National Institute for Medical Research, Tanzania
Federal Minstry of Health of Ethiopia
Jos University Teaching Hospital
University College London, UK.
RTI International
Sightsavers
World Health Organization
Pan American Health Organization
Investigators
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Principal Investigator: Emma Harding-Esch LSHTM

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03997487     History of Changes
Other Study ID Numbers: 2019-KEP-284 - 2
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will be shared with relevant study team members for the purposes of data analysis. Data Transfer Agreements will be completed, where appropriate.
Supporting Materials: Study Protocol
Time Frame: Data will be shared with team members as they are collected.
Access Criteria: Data access requests from outside the study team for the specified data analyses will be reviewed by the Principal Investigator. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chlamydia Infections
Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases