Digital Toolkit for Skin Diseases in LMICs: Part 2

NCT ID: NCT06292260

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Skin Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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With mHealth app

All healthcare providers will receive the mHealth app (eSkinHealth) to be used in their daily practices.

Group Type EXPERIMENTAL

mHealth app

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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


* 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

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


* Clinically diagnosed skin conditions outside of the target site
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hope Commission International

UNKNOWN

Sponsor Role collaborator

Institut Pasteur of Cote d'Ivoire

OTHER_GOV

Sponsor Role collaborator

Institut Raoul Follereau

UNKNOWN

Sponsor Role collaborator

Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

OTHER

Sponsor Role collaborator

Tokyo Medical and Dental University

OTHER

Sponsor Role collaborator

Tulane University

OTHER

Sponsor Role lead

Responsible Party

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Rie Yotsu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hope Commission International

Abidjan, , Côte d’Ivoire

Site Status RECRUITING

Countries

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Côte d’Ivoire

Central Contacts

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Rie R Yotsu, MD, MIPH, DTM&H, PhD

Role: CONTACT

+1-(504) 988-5388

Facility Contacts

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Aubin Yao, MS

Role: primary

Eric-Herman N'da Kouakou

Role: backup

Other Identifiers

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2020-2054-2

Identifier Type: -

Identifier Source: org_study_id

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