Asthma in ChildrenNCT03435822
Clinical Study on Chinese Children's Asthma Action Plan
A study testing asthma action plan management group and conventional management group in people with Asthma in Children, run by Beijing Children's Hospital.
Trial summary
This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to assess the efficacy of China Children Asthma Action Plan (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma management. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- asthma action plan management group and conventional management group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- did not receive control treatment or did not reach well-control;
- can perform spirometry pulmonary function tests;
- parents are skilled in using smartphones and APP apps (Android or IOS).
Who cannot join
- reach the level of asthma control;
- can not use the smartphone APP software;
- can not cooperate the test of peak expiratory flow;
- did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.);
- combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.).
- receiving allergen-specific immunotherapy.
- undergoing trial for other medications or instruments.
Trial locations and contacts
No sites are listed yet.
About this study
This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to assess the efficacy of China Children Asthma Action Plan (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma management.
Read the detailed description
Asthma is the most common chronic illness of childhood. Asthma action plans have been recommended internationally for more than 20 years by the Global Initiative for Asthma and have been shown to improve asthma-related outcomes. The first asthma action plan for children with asthma in China, which is termed China Children Asthma Action Plan（CCAAP）, as well as a mobile phone-based asthma self management application(APP), were developed recently.
The objective of the study is to assess the efficacy of CCAAP in asthma management.
The study is a multi-center prospective case-controlled study.The enrollment period is 3 months. Patients who is in 6-14 years of age will be randomized recruited into two groups: the asthma action plan group and the conventional group. Patients in asthma action plan group will receive written CCAAP and mobile phone-based asthma self-management APP (Youran Respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and Peak Expiratory Flow Meter. Patients in conventional management group will write down the symptoms and PEF in asthma diary. The data of the number of asthma episodes, the improvement of FEV1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, ACT / C-ACT score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of CCAAP in asthma management. The study will recruit 200 cases for each group from ten children's hospitals. The study will be completed in a year.
- Conditions
- Asthma in Children
- Being tested
- asthma action plan management group, conventional management group
- Keywords
- asthma, children, action plan, China, CCAAP
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asthma action plan management groupOther
Also called conventional management group
Patients will follow the directions in asthma action plan when their asthma get worse.
conventional management groupOther
Patients will follow the directions in conventional strategy when their asthma get worse.
| Study group | Role | What they receive |
|---|---|---|
| asthma action plan management group | Other | Patients in this group will be provided both written asthma action plan and mobile-based APP to remind them take medicine regularly and direct them what to do when asthma get worse. Receives: Other: asthma action plan management group |
| conventional management group | Other | Patients in this group will be provided conventional management method with prescriptions and asthma diaries. Receives: Other: conventional management group |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of acute episodes of asthma
number of acute episodes of asthma in a year
Measured: 1 year
Secondary outcomes (8)
the changes of FEV1 before and after management
the changes of FEV1 before and after management in a year
Measured: 1 year
the score of children's quality of life
pediatric asthma quality of life questionnaire contains 23 items in three domains, activity limitation（10）, symptoms（5） and emotional function（8）. The scale from 1-7 for each question. And the higher score the better quality of life.
Measured: 1 year
asthma knowledge
Knowledge, attitude and practice(KAP) questionnaire，contains 27 questions. Multivariate analysis will be carry out based on the answers to questions
Measured: 1 year
ACT / C-ACT score
the change of ACT / C-ACT score. there are 5 questions. For each questions, score ranks from 1 to five. Total score 25: well control, 20~24: control, less than 20: un ncontrol
Measured: 1 year
the absent days of school
the number of absent days of school because of asthma attack
Measured: 1 year
the absent days of parents' work
the number of absent days of parents' work because of children's asthma attack
Measured: 1 year
the cost of health economics
the cost of acute asthma exacerbation in a year
Measured: 1 year
the number of unscheduled medical care
the number of unscheduled medical care in a year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start22 Mar 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tian Jing Children's Hospital, Capital Institute of Pediatrics, China, Peking University Third Hospital, Beijing Tsinghua Chang Gung Hospital, Tianjin Medical University Second Hospital, Peking University Bin Hai Hospital, The First Hospital of Qinhuangdao, Tangshan Maternal and Child Health Hospital, Children's Hospital of Hebei Province
- Responsible party
- Principal investigator, Kunling Shen, Beijing Children's Hospital
- Investigators
- kunling Shen, MD,PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435822
- Sponsor's protocol ID
- BCHlung009
- Status last verified
- Mar 2018
- First submitted
- 12 Feb 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant available to other researchers so far.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Chinese Children's Asthma Action Plan
- ClinicalTrials.gov ID
- NCT03435822
- Acronym / sponsor ID
- BCHlung009
- Conditions
- Asthma in Children
- Keywords
- asthma, children, action plan, China, CCAAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Collaborators
- Tian Jing Children's Hospital, Capital Institute of Pediatrics, China, Peking University Third Hospital, Beijing Tsinghua Chang Gung Hospital, Tianjin Medical University Second Hospital, Peking University Bin Hai Hospital, The First Hospital of Qinhuangdao, Tangshan Maternal and Child Health Hospital, Children's Hospital of Hebei Province
- Study start
- 22 Mar 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to assess the efficacy of China Children Asthma Action Plan (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma management.
Detailed description
Asthma is the most common chronic illness of childhood. Asthma action plans have been recommended internationally for more than 20 years by the Global Initiative for Asthma and have been shown to improve asthma-related outcomes. The first asthma action plan for children with asthma in China, which is termed China Children Asthma Action Plan（CCAAP）, as well as a mobile phone-based asthma self management application(APP), were developed recently.
The objective of the study is to assess the efficacy of CCAAP in asthma management.
The study is a multi-center prospective case-controlled study.The enrollment period is 3 months. Patients who is in 6-14 years of age will be randomized recruited into two groups: the asthma action plan group and the conventional group. Patients in asthma action plan group will receive written CCAAP and mobile phone-based asthma self-management APP (Youran Respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and Peak Expiratory Flow Meter. Patients in conventional management group will write down the symptoms and PEF in asthma diary. The data of the number of asthma episodes, the improvement of FEV1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, ACT / C-ACT score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of CCAAP in asthma management. The study will recruit 200 cases for each group from ten children's hospitals. The study will be completed in a year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asthma action plan management group | Other | Other: asthma action plan management groupPatients in this group will be provided both written asthma action plan and mobile-based APP to remind them take medicine regularly and direct them what to do when asthma get worse. |
| conventional management group | Other | Other: conventional management groupPatients in this group will be provided conventional management method with prescriptions and asthma diaries. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- did not receive control treatment or did not reach well-control;
- can perform spirometry pulmonary function tests;
- parents are skilled in using smartphones and APP apps (Android or IOS).
Key exclusion criteria (7 listed)
- reach the level of asthma control;
- can not use the smartphone APP software;
- can not cooperate the test of peak expiratory flow;
- did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.);
- combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| asthma action plan management groupAlso: conventional management groupPatients will follow the directions in asthma action plan when their asthma get worse. | Other | asthma action plan management group |
| conventional management groupPatients will follow the directions in conventional strategy when their asthma get worse. | Other | conventional management group |
Primary outcome
number of acute episodes of asthma
Time frame: 1 year
number of acute episodes of asthma in a year
8 secondary outcomes
the changes of FEV1 before and after management
Time frame: 1 year
the score of children's quality of life
Time frame: 1 year
asthma knowledge
Time frame: 1 year
ACT / C-ACT score
Time frame: 1 year
the absent days of school
Time frame: 1 year
the absent days of parents' work
Time frame: 1 year
the cost of health economics
Time frame: 1 year
the number of unscheduled medical care
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant available to other researchers so far.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kunling Shen, MD,PhD principal investigator
Beijing Children's Hospital of Capital Medical University
Questions about this trial
What is this clinical trial studying?
A study testing asthma action plan management group and conventional management group in people with Asthma in Children, run by Beijing Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kunling Shen, MD,PhD (59616666 ext. 6308, kunlingshen1717@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of acute episodes of asthma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.