MIND-the-SKIN Project: Multi-functional Innovative Digital Toolkit for the Skin Diseases in LMICs and Beyond
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,364
- 试验地点
- 1
- 主要终点
- Differences in case numbers diagnosed and followed up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Differences in case numbers diagnosed and followed up
时间窗: 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.
次要结局
- Usability of the app(12 weeks)
- Effectiveness of the app(12 weeks)
研究者
Rie Yotsu
Associate Professor
Tulane University