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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Jingyi Li, M.D.
jingyili@wchscu.cn
+8618980605704
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 232
Treatments
Experimental: App group
Participants will be assisted to use the app during the process of management, 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.
No_intervention: Control group
The diagnosis, treatment, and follow-up of participants will be carried out according to the current routine on face-to-face basis. The time points of the participants follow-up will be determined by the responsible dermatologist, and the evaluation of five treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI will be done and recorded on the day of follow-up.
Related Therapeutic Areas
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov