NCT05659225

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 3, 2023

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

December 13, 2022

Last Update Submit

February 2, 2023

Conditions

Asthma

Keywords

PediatricAsthma ControlElectronic Stethoscope

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • asthma control

    1 year

  • adherence to asthma treatment

    1 year

Other Outcomes (9)

  • SABA use

    1 year

  • systemic corticosteroid use

    1 year

  • lung function

    1 year

  • +6 more other outcomes

Study Arms (2)

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.

Device: Electronic StethoscopeOther: Standard treatment according to GINA(2019)

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".

Other: Standard treatment according to GINA(2019)

Interventions

Electronic StethoscopeDEVICE

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.

Also known as: study-specified asthma device program
electronic stethoscope group
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).

control groupelectronic stethoscope group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Out-patient, female or male, 3 years old≤ age \< 6 years old
  • long-term maintenance therapy with inhaled glucocorticoids or concomitant leukotriene receptor antagonists
  • Equipped with a household atomizer or spacer, it can afford the inhalation therapy of short-acting β2 receptor agonists (SABA) at home
  • The subjects or subjects' caregiver must have a smart phone with Android or Harmony system at their disposal
  • The guardian agrees to participate in the study and signs the informed consent form

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Yong Yin, PhD

    Shanghai Children's Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yin, PhD

CONTACT

8618930830705yinyong9999@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 3, 2023

Record last verified: 2022-11

Locations

CN(1)