MIND-the-SKIN Project: Multi-functional Innovative Digital Toolkit for the Skin Diseases in LMICs and Beyond
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tulane University
- Enrollment
- 1,364
- Locations
- 1
- Primary Endpoint
- Differences in case numbers diagnosed and followed up
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Arms & Interventions
With mHealth app
Intervention: mHealth app (Device)
Without mHealth app
Outcomes
Primary Outcomes
Differences in case numbers diagnosed and followed up
Time Frame: 12 weeks
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.
Secondary Outcomes
- Usability of the app(12 weeks)
- Effectiveness of the app(12 weeks)
Investigators
Rie Yotsu
Associate Professor
Tulane University