Study Results
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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UNKNOWN
NA
1364 participants
INTERVENTIONAL
2022-02-14
2023-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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With mHealth app
mHealth app
The local healthcare providers will be assigned to an intervention group receiving the mHealth app to be used in their daily practices or a control group.
Without mHealth app
No interventions assigned to this group
Interventions
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mHealth app
The local healthcare providers will be assigned to an intervention group receiving the mHealth app to be used in their daily practices or a control group.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Difficulty operating mobile devices
Phase 3: Patients with skin diseases
* More than three skin conditions
* Clinically diagnosed skin conditions outside of the target site
ALL
No
Sponsors
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Osaka University
OTHER
Hope Commission International
UNKNOWN
Institut Pasteur of Cote d'Ivoire
OTHER_GOV
Institut Raoul Follereau
UNKNOWN
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
OTHER
Trilobite, Ltd.
UNKNOWN
Tulane University
OTHER
Responsible Party
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Rie Yotsu
Associate Professor
Locations
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Rie Yotsu
Sinfra, , Côte d’Ivoire
Countries
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Central Contacts
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Facility Contacts
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Rie Yotsu, Ph.D
Role: primary
References
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Yotsu RR, Almamy D, Vagamon B, Ugai K, Itoh S, Koffi YD, Kaloga M, Dizoe LAS, Kouadio K, Aka N, Yeboue LKG, Yao KA, Blanton RE. An mHealth App (eSkinHealth) for Detecting and Managing Skin Diseases in Resource-Limited Settings: Mixed Methods Pilot Study. JMIR Dermatol. 2023 Jun 14;6:e46295. doi: 10.2196/46295.
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.
Other Identifiers
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2020-2054
Identifier Type: -
Identifier Source: org_study_id
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