Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pediatric Asthma Control Under Community Management Model in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02649803
Recruitment Status : Unknown
Verified August 2016 by Shanghai Children's Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : January 7, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai Children's Medical Center

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: asthma APP Not Applicable

Detailed Description:

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. Asthma medicine will be prescribed by the investigator according to patient's asthma severity and control status. 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. The patient's caregiver will be instructed to install the study-specified application program (APP) at their smart phone and learn how to use this APP.

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".

The patients' caregiver will be prompted to fill out an asthma control questionnaire and asthma control test via their smart phone APP every month.

Patients will be requested to visit prearranged community hospitals at month 1, 3, 6, 9 and arrange their last visit back to Shanghai Children's Medical Center at month 12. During each onsite visit, asthma-related information will be collected by the investigators.

Meanwhile, subjects will receive PEF (>5 years old) and FENO tests for evaluation of lung function and inflammation level. After comprehensive assessment of the patient's symptom control, risk factors, occurrence of exacerbations, and practical issues (cost, ability to use the device, and adherence), the investigator will make the decision on whether stepping up or stepping down asthma treatment.

This study ends up without follow-up.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pediatric Asthma Control Under Community Management Model in China
Study Start Date : March 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
community hospital
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
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.
Other Name: study-specified asthma application program




Primary Outcome Measures :
  1. asthma control questionnaire [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. asthma control test [ Time Frame: 1 year ]
    caregiver will also be asked to fill out an asthma control test (for patients 12 years or older) , childhood asthma control test (for patients aged 5-12) , or GINA assessment of asthma control in children 5 years and younger.


Other Outcome Measures:
  1. FENO tests [ Time Frame: 1 year ]
    Subjects will receive FENO(Fractional exhaled nitric oxide, parts per billion, ppb) tests for evaluation of lung inflammation level.

  2. PEF (>5 years old) [ Time Frame: 1 year ]
    Subjects(older than 5 years) will receive PEF (Peak expiratory flow, L/min) tests for evaluation of lung function.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649803


Locations
Layout table for location information
China, Shanghai
Shanghai children's medical center
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Children's Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Yong Yin, PhD Shanghai Children's Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Shanghai Children's Medical Center
ClinicalTrials.gov Identifier: NCT02649803    
Other Study ID Numbers: ESR-15-10989
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shanghai Children's Medical Center:
pediatric
asthma control
community
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases