Telemedicine System and Intelligent Monitoring System Construction of Pediatric Asthma Based on the Electronic Stethoscope

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Device: Electronic Stethoscope; Other: Standard treatment according to GINA(2019)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Yin, PhD; Phone Number: 8618930830705; Email: yinyong9999@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: electronic stethoscope group; During the study, subjects who diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" will be assigned to the control group and the electronic stethoscope group, and receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". The patient's caregiver will be instructed to use an electronic stethoscope to coordinate treatment and complete follow-up.	Device: Electronic Stethoscope; Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. 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.; Other Names: study-specified asthma device program; Other: Standard treatment according to GINA(2019); Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. The patient's caregiver who was assigned to the control group will receieve standard treatment according to GINA(2019).
Other: control group; During the study, subjects who diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" will be assigned to the control group and the electronic stethoscope group, and receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children".	Other: Standard treatment according to GINA(2019); Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. The patient's caregiver who was assigned to the control group will receieve standard treatment according to GINA(2019).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visits of asthma-related unplanned emergency department	Subjects will fill out a questionnaire to provide the number of unscheduled emergency department visits related to asthma (except for routine asthma follow-up visits every 3 months).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
asthma control	The patients' caregiver will be prompted to fill out an asthma control questionnaire every month. This questionnaire contains questions regarding renewal of prescription, control status and asthma attack.	1 year
adherence to asthma treatment	Patients' adherence will be assessed by investigator through questionnaire.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SABA use	Number of days and total amount of SABA use will be collected by investigator through questionnaire.	1 year
systemic corticosteroid use	Days of systemic corticosteroid use will be counted by investigator through questionnaire.	1 year
lung function	Subjects (equal or older than 4 years) will receive PEF (Peak expiratory flow, L/min) tests for evaluation of lung function.	1 year
FENO tests	Subjects will receive FENO (Fractional exhaled nitric oxide, parts per billion, ppb) tests for evaluation of lung inflammation level.	1 year
Asthma-related medical expenses	Asthma-related medical expenses will be counted by investigator through questionnaire.	1 year
Asthma-related hospitalizations	Number of asthma-related hospitalizations will be collected by investigator through questionnaire.	1 year
Missed school and parents missed work	Number of missed school and parents missed work will be collected by investigator through questionnaire.	1 year
Patients' and caregivers' quality of life	Patients' and caregivers' quality of life will be evaluated by investigator through questionnaire.	1 year
Caregivers' satisfaction degree with electronic stethoscopes	Caregivers' satisfaction degree with electronic stethoscopes will be assessed by investigators through questionnaire.	1 year

Collaborators and Investigators

• Sponsor: Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pediatric; Asthma Control; Electronic Stethoscope
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: SCMCIRB-YJ2022002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No