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Smartphone App for Taking Images of Conjunctivae

Primary Purpose

Trachoma

Status
Terminated
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
TOFTEE
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Trachoma

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arusha region

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children examined

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Kappa score of TOFTEE image compared with field grading
Concordance in diagnosis of trachoma between field grading and app image
Kappa score of TOFTEE image compared with DSLR grading
Concordance in diagnosis of trachoma between app image and DSLR image
Kappa score of DSLR image compared with field grading
Concordance in diagnosis of trachoma between field grading and DSLR image

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
June 19, 2019
Last Updated
August 18, 2022
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, University College London Hospitals, RTI International, Sightsavers, World Health Organization, Pan American Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT03997487
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Institute for Medical Research, Tanzania, Federal Minstry of Health of Ethiopia, Jos University Teaching Hospital, University College London Hospitals, RTI International, Sightsavers, World Health Organization, Pan American Health Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children examined
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TOFTEE
Intervention Description
Smartphone app for taking quality images of conjunctivae
Primary Outcome Measure Information:
Title
TOols For Trachoma Elimination Endgame (TOFTEE) app image quality
Description
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.
Time Frame
30 minutes
Title
Kappa score of TOFTEE image compared with field grading
Description
Concordance in diagnosis of trachoma between field grading and app image
Time Frame
5 minutes
Title
Kappa score of TOFTEE image compared with DSLR grading
Description
Concordance in diagnosis of trachoma between app image and DSLR image
Time Frame
5 minutes
Title
Kappa score of DSLR image compared with field grading
Description
Concordance in diagnosis of trachoma between field grading and DSLR image
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics and TOFTEE image quality
Description
Association (reported as proportions, unadjusted and adjusted odds ratios) between child characteristics acceptable photo quality
Time Frame
15 minutes
Title
Acceptability and feasibility of TOFTEE app in communities
Description
Common themes, as determined through thematic analysis of focus group discussion transcripts, relating to acceptability and feasibility of TOFTEE app in communities
Time Frame
45 minutes
Title
Acceptability and feasibility of TOFTEE app in Tropical Data system
Description
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
Time Frame
45 minutes
Title
Cost of TOFTEE app implementation
Description
Cost (overall and broken down by category: personnel; supplies; transit; telecommunications) of TOFTEE app implementation into the Tropical Data system
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Harding-Esch
Organizational Affiliation
LSHTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arusha region
City
Arusha
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will be shared with team members as they are collected.
IPD Sharing 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.

Learn more about this trial

Smartphone App for Taking Images of Conjunctivae

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