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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.
(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.
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electronic stethoscope group | Other | 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. |
|
| control group | Other | 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". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Stethoscope | Device | 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. |
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Yin, PhD | Contact | 8618930830705 | yinyong9999@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong Yin, PhD | Shanghai Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children's Medical Center | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Standard treatment according to GINA(2019) | Other | 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). |
|
Patients' adherence will be assessed by investigator through questionnaire. |
| 1 year |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |