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临床试验/CTRI/2025/01/078963
CTRI/2025/01/078963尚未招募不适用

Evaluating the Effectiveness of an AI Enhanced Mobile Application in Improving Management Outcomes for Atopic Dermatitis Patients A Randomized Controlled Trial

IADVL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
IADVL
入组人数
100
试验地点
1
主要终点
Change in SCORAD (Scoring Atopic Dermatitis) index from baseline to 12 weeks.

研究概览

简要总结

This research project evaluates the effectiveness of an AI-powered mobile app designed to manage atopic dermatitis over two years. We aim to test whether this app can enhance treatment adherence and patient outcomes compared to traditional care methods. Initially, the project will focus on developing the app, which will include features to monitor disease severity, provide medication reminders, and offer educational support through an integrated chatbot.

Following development, the project will conduct a 15-month randomized controlled trial involving 100 patients. The effectiveness of the app will be assessed using the SCORAD index to measure changes in disease severity, alongside evaluations of treatment adherence, quality of life improvements, and patient satisfaction. The study aims to demonstrate that digital tools can significantly improve the management and outcomes of chronic dermatological conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with atopic dermatitis by a dermatologist.
  • Ages 18 and above.
  • Smartphone users willing to use the app.

排除标准

  • Patients with other primary skin disorders.
  • Patients with severe atopic dermatitis requiring systemic therapy.
  • Current participation in another clinical trial.

结局指标

主要结局

Change in SCORAD (Scoring Atopic Dermatitis) index from baseline to 12 weeks.

时间窗: Change in SCORAD (Scoring Atopic Dermatitis) index from baseline to 12 weeks.

次要结局

  • changes in POEM scores, changes in DLQI scores, and patient satisfaction with the AI-enabled application at 12 weeks.(12 weeks)

研究者

发起方
IADVL
申办方类型
Other [national association of dermatologist]
责任方
Principal Investigator
主要研究者

Neena Khanna

Amrita Hospital

研究点 (1)

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