Actively Recruiting

Phase Not Applicable
Age: 1Year - 75Years
All Genders
ID06362629

Construction and Evaluation of an Artificial Intelligence Assistant Decision-making System Focused on the Treat to Target Framework and Full Process Management for Atopic Dermatitis

Led by West China Hospital · Updated on 2024-10-15

232

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Atopic dermatitis (AD) is a long-lasting skin condition marked by repeated rashes and itching, which seriously impacts patients' quality of life and creates a significant economic burden. Researchers are evaluating an Artificial Intelligence assistant decision-making system (AIADMS) app that integrates the Treat to Target (T2T) strategy to improve disease control and clinical outcomes for patients with moderate to severe AD. This project aims to develop, train, and test the AIADMS app through clinical trials to verify its effectiveness and safety in managing AD. The AIADMS app is designed for both patients and clinicians with features such as reminders, photo uploads, self-evaluation, and data management. The app uses a deep learning model trained on over 10,000 clinical images to assess AD severity and clinical signs. Participants in the treatment group will use the app for disease management and be followed up at scheduled times up to 12 months after treatment, while the control group will receive routine face-to-face care. The app supports Android and iOS and provides automated assessments using tools like EASI, POEM, SCORAD, PP-NRS, and DLQI to help patients and clinicians monitor progress. Participants will have follow-up visits at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months after treatment. During these visits, evaluations using five treatment objectives will be performed. Data collected will include clinical scores, economic consumption, and satisfaction evaluations. The primary outcome is the overall efficiency rate of treatment objectives at 12 weeks. The study also involves tracking safety and patient adherence, with the entire study period lasting up to 12 months.

CONDITIONS

Brief Title

AI App for Management of Atopic Dermatitis

Who Can Participate

Age: 1Year - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with atopic dermatitis
  • Aged 1 to 75 years
  • Able to communicate in Chinese
  • Have basic reading and writing skills
  • Participant or guardian owns and can use a smartphone or tablet
Not Eligible

You will not qualify if you...

  • Mental illness or personality disorder
  • Language barrier, hearing impairment, or communication difficulties
  • Serious coexisting diseases such as cardiopulmonary insufficiency, liver dysfunction, renal dysfunction, blood system diseases, tumors, or other serious conditions
  • Other conditions unsuitable for clinical trial participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 12 months

Participants in the app group will use the Artificial Intelligence assistant decision-making system (AIADMS) app to assist in managing atopic dermatitis. Participants in the control group will receive routine face-to-face diagnosis, treatment, and follow-up according to current standards.

Follow-up visits at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months after treatment

Trial Site Locations

Total: 1 location

1

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

J

Jingyi Li, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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