跳至主要内容
临床试验/NCT06292260
NCT06292260招募中不适用

Multi-functional Innovative Digital Toolkit for the Skin Diseases n LMICs and Beyond

Tulane University2 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2024年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Number of cases of each skin NTD (neglected tropical disease) and other skin conditions as compared to the pre-intervention

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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 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

排除标准

  • Planning to leave their job at the clinics within the study period
  • Difficulty operating mobile devices
  • 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

结局指标

主要结局

Number of cases of each skin NTD (neglected tropical disease) and other skin conditions as compared to the pre-intervention

时间窗: 12 months

Differences in case numbers diagnosed and followed up between the rural and urban areas. The case numbers will be retrieved from the eSkinHealth server registry which data will be exported to Excel for analysis.

次要结局

  • Capacity building and effectiveness of training(12 months)
  • Case confirmation rate for each skin NTD (neglected tropical disease) and other skin conditions by dermatologists(12 months)
  • Number of days from registry to confirmatory diagnosis(12 months)
  • Feasibility, usability, and effectiveness of the surveillance approach using eSkinHealth app(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rie Yotsu

Associate Professor

Tulane University

研究点 (2)

Loading locations...

相似试验