NCT02649803

Brief Summary

The purpose of this study is to learn the pediatric asthma control status under community management model. To learn the differences of pediatric asthma control status when subjects assigned to community hospitals or Shanghai Childrens Medical Centre. To learn the treatment adherence and the frequency of asthma attack under community management model.

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
800

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Mar 2016

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

January 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

January 1, 2016

Last Update Submit

August 12, 2016

Conditions

Asthma

Keywords

pediatricasthma controlcommunity

Outcome Measures

Primary Outcomes (1)

  • asthma control questionnaire

    The patients' caregiver will be prompted to fill out an asthma control questionnaire via their smart phone APP every month. This questionnaire contains questions regarding renewal of prescription, adherence, control status, asthma attack and health economic information.

    1 year

Secondary Outcomes (1)

  • asthma control test

    1 year

Other Outcomes (2)

  • FENO tests

    1 year

  • PEF (>5 years old)

    1 year

Study Arms (1)

community hospital

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 nearest community hospital or Shanghai Children's Medical Center, 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 install asthma APP at their smart phone to follow up.

Behavioral: asthma APP

Interventions

asthma APPBEHAVIORAL

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 nearest community hospital or Shanghai Children's Medical Center, whichever is nearer to the subject's home, for their future onsite visits (V2-V5). The patient's caregiver will be instructed to install the asthma APP at their smart phone and learn how to use this APP.

Also known as: study-specified asthma application program
community hospital

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Out-patient, female or male, aged less than 18 years old
  • Diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children"
  • Consent should be obtained by subjects' guardian
  • The subjects or subjects' caregiver must have a smart phone at their disposal

You may not qualify if:

  • Presenting with differential diagnosis of asthma such as congenital heart disease, gastro-oesophageal reflux, bronchopulmonary dysplasis, bronchiolitis obliterans, etc.
  • Allergy to any inhaler cortical steroid
  • Subject with other diseases that may interfere the study results judged by the investigators.
  • Participation in any analogous clinical study within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai children's medical center

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • Zhang J, Zhao L, Zhao D, Chen Z, Li S, Zhang H, Zhang L, Yuan S, Tang M, Wu Y, Zhong W, Xu J, Zhao LX, Liu SY, Hong J, Yin Y. Reliability and validity of the Chinese version of the Test for Respiratory and Asthma Control in Kids (TRACK) in preschool children with asthma: a prospective validation study. BMJ Open. 2019 Aug 26;9(8):e025378. doi: 10.1136/bmjopen-2018-025378.

    PMID: 31455696DERIVED

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

Study Design

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

Study Record Dates

First Submitted

January 1, 2016

First Posted

January 7, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2018

Study Completion

June 1, 2019

Last Updated

August 15, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)