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AI App for Management of Atopic Dermatitis

NCT06362629 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2024-10-15

No results posted yet for this study

Summary

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurrent rashes and itching, which seriously affects the quality of life of patients and brings heavy economic burden to society. The Treat to Target (T2T) strategy was proposed to guide optimal use of systemic therapies in patients with moderate to severe AD, and it is emphasized patients' adherence and combined evaluation from both health providers and patients. While effective treatments for AD are available, non-adherence of treatment is common in clinical practice due to the patients' unawareness of self-evaluation and lack of concern about the specific follow-up time points in clinics, which leads to the treatment failure and repeated relapse of AD.

Hypothesis: An Artificial Intelligence assistant decision-making system (AIADMS) with implementation of the T2T framework could help control the disease progression and improve the clinical outcomes for AD.

Overall objectives:

the investigators aim to develop an AIADMS in the form of smartphone app to integrate T2T approach for both clinicians and patients, and design clinical trials to verify the effectiveness and safety of the app. Methods: This project consists of three parts, AI training model for diagnosis and severity grading of AD based on deep learning, development of Artificial Intelligence assistant decision-making system (AIADMS) in the form of app, and design of a randomized controlled trial to verify the effectiveness and safety of AIADMS App for improvement of the clinical outcomes in AD patients.

Expected results: With application of AIADMS based app, the goal of T2T for patients with AD could be realized better, the prognosis could be improved, and more satisfaction could be achieved for both patients and clinicians.

Impact: This is the first AIADMS based app for AD management running through thediagnosis, patients' self-participation, medical follow-up, and evaluation of achievement of goal of T2T.

Conditions

Interventions

BEHAVIORAL

Artificial Intelligence assistant decision-making system (AIADMS) App

Participants will be assisted to use the Artificial Intelligence assistant decision-making system (AIADMS) app during the process of management of AD, and be followed-up at the scheduled time points including 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months and 12 months after treatment, and the evaluation of five treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI should be done on the day of follow-up.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Jingyi Li, M.D. · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2028-12-31
Completion
2029-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06362629 on ClinicalTrials.gov