Clinical trial NCT05659225: Telemedicine System and Intelligent Monitoring System Construction of Pediatric Asthma Based on the Electronic Stethoscope
Official title: Telemedicine System and Intelligent Monitoring System Construction of Pediatric Asthma Based on the Electronic Stethoscope
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Pediatric
Asthma Control
Electronic Stethoscope
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 208
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to retrofit the existing electronic stethoscope, improve the quality and efficiency of signal acquisition and the intelligent degree of information processing, decrease the manual action of electronic stethoscopes implemented by parents of asthma children, simplify the process of data transfer and the user's operational cost using signal processing, artificial intelligence technology, thus decreasing the feedback cycle between patients and clinicians. Eventually, we will construct an intelligent monitoring system based on the modified electronic stethoscope and explore the interactive remote management approaches on children's asthma at the same time, thus achieving revolutionized remote management of asthma.

Detailed description: (1) The design of hardware and software of the intelligent electronic stethoscope This project will optimize and develop the software and hardware equipment of electronic stethoscope according to the shortcomings of existing electronic stethoscopes.

1. Get high-quality breath sound data through integrated ECG sensor and algorithms for denoising and the separation of heart sound and lung sound
2. Develop algorithms and corresponding frameworks for visualization of breath sounds and mining of key information
3. Develop algorithms for automatic recognition of abnormal breath sounds
4. Transfer breath sound data efficiently and reliably based on the encoding-decoding architecture
5. Optimize the breath sound data transmission process
6. Construct the remote diagnosis and treatment methods and monitoring system for childhood asthma preliminary

(2) The effect of telemedicine system and intelligent monitoring system based on intelligent stethoscope on children with asthma Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as baseline medical condition will be collected by the investigators. The subject will be randomly assigned to the control group and the electronic stethoscope group. The patient's caregiver who was assigned to the electronic stethoscope group will be instructed to install the electronic stethoscope developed by our team and its accessories, then they will be trained by investigators on how to use the electronic stethoscope.

During the study, patients will receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". If patients develop upper respiratory tract symptoms without fever, the investigator will give corresponding guidance to the control group and the electronic stethoscope group. If fever develops, it is recommended that patients directly go to the emergency department.

All patients' caregiver will be prompted to finish the test for respiratory and asthma control in kids (TRACK) every month. Patient's caregiver assigned to the electronic stethoscope group will also need to complete the collection, data upload and sharing of patient's breath sounds at least once a month to confirm that the electronic stethoscope is worked correctly.

After enrollment, patients will be requested to visit Shanghai Children's Medical Center at month 3, 6, 9, 12. During each onsite visit, subjects will receive lung function (≥4 years) and FENO tests and fill out the questionnaire regarding the number of asthma-related outpatient emergency department visits, asthma-related hospitalizations, SABA and systemic glucocorticoid use, missed work and school misses, and asthma-related medical expenses in the past 3 months. At 6- and 12-month's visit, pediatric asthma caregiver's quality of Life questionnaire (PACQLQ) needs to be completed at the same time.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" in the respiratory clinic of Shanghai Children's Medical Center from January 2023 to January 2025
2. Out-patient, female or male, 3 years old≤ age \< 6 years old
3. long-term maintenance therapy with inhaled glucocorticoids or concomitant leukotriene receptor antagonists
4. Equipped with a household atomizer or spacer, it can afford the inhalation therapy of short-acting β2 receptor agonists (SABA) at home
5. The subjects or subjects' caregiver must have a smart phone with Android or Harmony system at their disposal
6. The guardian agrees to participate in the study and signs the informed consent form

Exclusion Criteria:

1. Acute exacerbation of asthma 30 days before enrollment (receive short-term prednisone treatment, emergency department visit or hospitalization due to acute asthma attacks)
2. Other chronic lung diseases, cardiovascular diseases, blood system diseases, immunodeficiency diseases, neurological diseases, genetic or chromosomal abnormalities and other underlying diseases
3. Patients or their caregivers can't complete the collection of breath sound

Primary outcomes:
measure: visits of asthma-related unplanned emergency department
timeFrame: 1 year
Secondary outcomes:
measure: asthma control
timeFrame: 1 year
measure: adherence to asthma treatment
timeFrame: 1 year
Other outcomes:
measure: SABA use
timeFrame: 1 year
measure: systemic corticosteroid use
timeFrame: 1 year
measure: lung function
timeFrame: 1 year
measure: FENO tests
timeFrame: 1 year
measure: Asthma-related medical expenses
timeFrame: 1 year
measure: Asthma-related hospitalizations
timeFrame: 1 year
measure: Missed school and parents missed work
timeFrame: 1 year
measure: Patients' and caregivers' quality of life
timeFrame: 1 year
measure: Caregivers' satisfaction degree with electronic stethoscopes
timeFrame: 1 year
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yong Yin, PhD
role: PRINCIPAL_INVESTIGATOR
References: