Clinical trial NCT06292260: Digital Toolkit for Skin Diseases in LMICs: Part 2
Official title: Multi-functional Innovative Digital Toolkit for the Skin Diseases n LMICs and Beyond
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Diseases
Keywords: Skin Diseases
Neglected Diseases
Teledermatology
Telemedicine
Remote Consultation
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Hope Commission International
name: Institut Pasteur of Cote d'Ivoire
name: Institut Raoul Follereau
name: Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
name: Tokyo Medical and Dental University
First posted: 2024-03-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of cases of each skin NTD (neglected tropical disease) and other skin conditions as compared to the pre-intervention
timeFrame: 12 months
Secondary outcomes:
measure: Case confirmation rate for each skin NTD (neglected tropical disease) and other skin conditions by dermatologists
timeFrame: 12 months
measure: Number of days from registry to confirmatory diagnosis
timeFrame: 12 months
measure: Feasibility, usability, and effectiveness of the surveillance approach using eSkinHealth app
timeFrame: 12 months
measure: Capacity building and effectiveness of training
timeFrame: 12 months
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: Hope Commission International
Study officials:
References: