Clinical trial NCT05300399: Digital Toolkit for Skin Diseases in LMICs
Official title: MIND-the-SKIN Project: Multi-functional Innovative Digital Toolkit for the Skin Diseases in LMICs and Beyond
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Diseases
Keywords: Skin Diseases
Neglected Diseases
Teledermatology
Telemedicine
Remote Consultation
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Osaka University
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: Trilobite, Ltd.
First posted: 2022-03-29
Enrollment: 1364
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the early detection and effective management of skin diseases using the mHealth app in Cote d'Ivoire, a mixed-methods pilot trial will be conducted in Cote d'Ivoire. The pilot trial will consist of 3 phases: phase 1, development and improvement of the mHealth app; phase 2, pilot trial to evaluate the usability of the mHealth app for local healthcare providers in Cote d'Ivoire; and phase 3, pilot trial to evaluate the effectiveness of case detection and management of skin diseases with the mHealth app in Cote d'Ivoire. The pilot study will be implemented as a 2-arm trial with local healthcare providers and patients with skin diseases over a 3-month follow-up period.

Detailed description: Background: The prevalence of skin diseases is extremely high in sub-Saharan Africa, among which are skin neglected tropical diseases (skin NTDs) that could lead to life-long disabilities and deformities if not diagnosed and treated early. To achieve early detection and early treatment of these skin diseases, we developed a mobile health application (mHealth app): 'eSkinHealth'.

Objective: To evaluate the early detection and effective management of skin diseases using the mHealth app in Cote d'Ivoire.

Methods: A mixed-methods pilot trial will be conducted in Cote d'Ivoire and will consist of 3 phases: phase 1, development and improvement of the mHealth app; phase 2, pilot trial to evaluate the usability of the mHealth app for local healthcare providers in Cote d'Ivoire; and phase 3, pilot trial to evaluate the effectiveness of case detection and management of skin diseases with the mHealth app in Cote d'Ivoire. The pilot study will be implemented as a 2-arm trial with local healthcare providers and patients with skin diseases over a 3-month follow-up period.

Local healthcare providers (i.e., doctors, nurses, or community health workers/volunteers) must meet all eligibility requirements to enroll in the study. Eligible local healthcare providers are; (1) 18 years or older, (2) working at primary health centers or clinics in Cote d'Ivoire, (3) able to read and speak fluent French, (4) willing to participate in the pilot study for the 3-month study duration and use a provided tablet with the eSkinHealth app if they were assigned in the intervention group, and (5) able to consent for oneself. Ineligible local healthcare providers will be defined as those who (1) are planning to leave the job at the clinics within the study period and (2) have difficulty in operating mobile devices.

Eligible patients will be defined as those are; (1) clinically suspected or diagnosed of skin NTDs (Buruli ulcer, leprosy, lymphatic filariasis, yaws, or other skin NTDs) or have other clinically diagnosed skin conditions, (2) diagnosed of concomitantly fewer than three identified skin conditions, and (3) able to consent for oneself. Ineligible patients have (1) more than three skin conditions and (2) clinically diagnosed skin conditions outside of the target site.

For phase 2, we will use a validated questionnaire, the system usability scale (SUS). The outcome measurement is an average score of SUS. The SUS consists of 10 statements with responses in the form of a five-point Likert scale (e.g., 1: strongly disagree, 5: strongly agree). We will use the French-language version of SUS. We will assess the usability at baseline, midpoint (6 weeks), and at the end of the study (12 weeks).

For phase 3, differences in case numbers diagnosed and followed up between the intervention group (with the app) and the control group (without the app) will be measured as the primary outcome of this study. We will also evaluate the effectiveness of the intervention on secondary outcomes, including engagement with the app's platform and willingness to use it. The engagement of local healthcare providers will be measured via data usage, including the frequency of visits to the platform and time spent there.

Eligibility criteria: Phase 2: Local 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 3-month study duration and 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

Phase 3: 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
* Diagnosed of concomitantly fewer than three identified skin conditions
* Able to consent for oneself

Exclusion Criteria:

* More than three skin conditions
* Clinically diagnosed skin conditions outside of the target site

Primary outcomes:
measure: Differences in case numbers diagnosed and followed up
timeFrame: 12 weeks
Secondary outcomes:
measure: Effectiveness of the app
timeFrame: 12 weeks
measure: Usability of the app
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sinfra
country: Côte D'Ivoire
facility: Rie Yotsu
Study officials:
References:
citation: Yotsu RR, Itoh S, Yao KA, Kouadio K, Ugai K, Koffi YD, Almamy D, Vagamon B, Blanton RE. The Early Detection and Case Management of Skin Diseases With an mHealth App (eSkinHealth): Protocol for a Mixed Methods Pilot Study in Cote d'Ivoire. JMIR Res Protoc. 2022 Sep 21;11(9):e39867. doi: 10.2196/39867.