Digital Toolkit for Skin Diseases in LMICs: Part 2 (MIND-the-SKIN2)

April 15, 2024 updated by: Rie Yotsu, Tulane University

Multi-functional Innovative Digital Toolkit for the Skin Diseases n LMICs and Beyond

Impact evaluation of eSkinHealth in improving case detection of skin NTDs and treatment outcomes in rural and urban settings

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A key component of integrated community-based surveillance using the digital health tool is to boost case detection for skin NTDs in the co-endemic target regions as well as to support follow-up management of those cases detected. The project uses the 'eSkinHealth' app which the investigators developed. The application offers a platform for facilitating field-based screening by community health workers (CHWs) and assisting primary healthcare workers (PHWs) (i.e., nurses in the case of Côte d'Ivoire) in remote diagnosis and case management through teledermatology involving specialized dermatologist. Upon consultation, identification and demographic data will be collected from an individual with suspected lesions and photos of skin lesions will be taken and uploaded in the patient files. These will then be cross-checked by remote dermatologists to confirm the clinical diagnosis and facilitate referral of identified cases to the health facility for early initiation of treatment. When patients are enrolled for treatment, regular remote dermatological consultations are expected to improve the follow-up and ensure better treatment outcomes.

For the evaluation of eSkinHealth app performance for this study, comparison will be made on the impact of having the app between rural and urban settings. This approach will allow the assessment whether the system is useful and expandable to a wider region of Côte d'Ivoire. The evaluation will be performed with focus on skin NTDs (such as Buruli ulcer, leprosy, mycetoma, lymphatic filariasis, scabies, and yaws) as the target diseases as these are chronic conditions with well-described disease course.

A total of 48 PHWs from two health districts of Abidjan will be selected. They will be compared against the 48 PHWs from Sinfra and Bouaflé health districts who had been a part of the previous study.

Trainings on eSkinHealth app, dermatological photography, and skin NTDs and basic dermatology will be provided to our participants. Patients with skin lesions will be asked to be part of the study and will be registered in the eSkinHealth app upon informed consent. Remote dermatologists will be recruited on a voluntary basis. Diagnosed cases will be managed and followed up as per national guidelines for each disease.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rie R Yotsu, MD, MIPH, DTM&H, PhD
  • Phone Number: +1-(504) 988-5388
  • Email: ryotsu@tulane.edu

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  1. Healthcare providers (i.e., doctors, nurses, or community health workers/volunteers)

    Inclusion Criteria:

    • 18 years or older
    • Working at primary health centers or clinics in Cote d'Ivoire
    • Able to read and speak fluent French
    • Willing to participate in the pilot study for the 12-month study duration
    • Willing to use a provided tablet with the eSkinHealth app if they were assigned to the intervention group
    • Able to consent for oneself

    Exclusion Criteria:

    • Planning to leave their job at the clinics within the study period
    • Difficulty operating mobile devices
  2. Patients with skin diseases

Inclusion Criteria:

  • Clinically suspected or diagnosed with skin NTDs (Buruli ulcer, leprosy, and yaws) or have other clinically diagnosed skin conditions
  • Able to consent for oneself

Exclusion Criteria:

  • Clinically diagnosed skin conditions outside of the target site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With mHealth app
All healthcare providers will receive the mHealth app (eSkinHealth) to be used in their daily practices.
Device: mHealth app
The eSkinHealth app is a tablet application that can be used as a portable patient chart for dermatological conditions in areas with poor internet connectivity, and for teledermatology when in need.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases of each skin NTD (neglected tropical disease) and other skin conditions as compared to the pre-intervention
Time Frame: 12 months
Differences in case numbers diagnosed and followed up between the rural and urban areas. The case numbers will be retrieved from the eSkinHealth server registry which data will be exported to Excel for analysis.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Case confirmation rate for each skin NTD (neglected tropical disease) and other skin conditions by dermatologists
Time Frame: 12 months
Case confirmation data by dermatologists will be retrieved from the eSkinHealth server registry which data will be exported to Excel for analysis.
12 months
Number of days from registry to confirmatory diagnosis
Time Frame: 12 months
Dates of registry and diagnosis will be retrieved from the eSkinHealth server registry which data will be exported to Excel for analysis.
12 months
Feasibility, usability, and effectiveness of the surveillance approach using eSkinHealth app
Time Frame: 12 months
This will be evaluated using the System Usability Scale (SUS) tool and semi-structured in-depth interviews.
12 months
Capacity building and effectiveness of training
Time Frame: 12 months
This will be evaluated using the pre- and post-test results and by diagnostic accuracy by primary health workers (PHWs) over time measured through the eSkinHealth server registry.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University

Collaborators

Tokyo Medical and Dental University
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Institut Pasteur of Cote d'Ivoire
Hope Commission International
Institut Raoul Follereau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-2054-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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