Digital Toolkit for Skin Diseases in LMICs: Part 2

Skin Diseases Clinical Trial

— MIND-the-SKIN2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292260
• Other study ID #: 2020-2054-2
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Tulane University
• Contact: Rie R Yotsu, MD, MIPH, DTM&H, PhD
• Phone: +1-(504) 988-5388
• Email: ryotsu[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Diseases

Intervention

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.

Locations

Country	Name	City	State
Côte D'Ivoire	Hope Commission International	Abidjan

Sponsors (6)

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

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases of each skin NTD (neglected tropical disease) and other skin conditions as compared to the pre-intervention	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	Case confirmation rate for each skin NTD (neglected tropical disease) and other skin conditions by dermatologists	Case confirmation data by dermatologists will be retrieved from the eSkinHealth server registry which data will be exported to Excel for analysis.	12 months
Secondary	Number of days from registry to confirmatory diagnosis	Dates of registry and diagnosis will be retrieved from the eSkinHealth server registry which data will be exported to Excel for analysis.	12 months
Secondary	Feasibility, usability, and effectiveness of the surveillance approach using eSkinHealth app	This will be evaluated using the System Usability Scale (SUS) tool and semi-structured in-depth interviews.	12 months
Secondary	Capacity building and effectiveness of training	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