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
Trial ID: NCT06362629
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-09-01
Completion date: 2029-08-31
Sponsor: West China Hospital
Conditions: Atopic Dermatitis; Artificial Intelligence
Interventions: Artificial Intelligence assistant decision-making system (AIADMS) App
Locations: West China Hospital, Sichuan University
Countries: China
Enrollment: 232
Age range: 1 Year - 75 Years
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* Diagnosed with AD, aged 1\~75 years; be able to communicate in Chinese; with basic reading and writing skills; participants or the guardian have smartphones or pads and are familiar with the use skills.

Exclusion Criteria:

* Mental illness; personality disorder; language barrier; hearing impairment; communication difficulties; with serious coexisting diseases, such as cardiopulmonary insufficiency, liver dysfunction, renal dysfunction, blood system diseases, tumors, or other diseases; other situations that not suitable for participating in clinical trial.

Outcomes:
The overall efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI at 12 weeks after treatment