AsthmaNCT06112405
Real World App-based CCAAP Management of Children With Asthma
A study testing App-based CCAAP and Written CCAAP in people with Asthma, 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 compare the App-based efficacy of China Children Asthma Action Plan (CCAAP) and written CCAAP used in management of children with asthma. The main questions are:1. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- App-based CCAAP and Written CCAAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2023to 31 Dec 2024
- 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 17 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 well 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
Official title: Evaluation of App-based Management of Children's Asthma Based on Real World Data and Randomized Control Trial
This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to compare the App-based efficacy of China Children Asthma Action Plan (CCAAP) and written CCAAP used in management of children with asthma. The main questions are:1. Is the App-based CCAAP effective/feasible in management of children with asthma? 2. Is the App-based CCAAP better than written CCAAP in management of children with asthma?
Read the detailed description
The study is a multi-center randomized control study.The enrollment period is 3 months. Patients who is in 6-17 years of age will be randomized recruited into two groups: the App-based asthma action plan group and the written CCAAP group. Patients in App 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 written CCAAP 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 400 cases for each group from ten children's hospitals. The study will be completed in a year.
- Conditions
- Asthma
- Being tested
- App-based CCAAP, Written CCAAP
- Keywords
- asthma, children, action plan, App-based
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based CCAAPOther
App-based CCAAP, could remind patients take controller and reliever when asthma symptoms get worse through mobile.
Written CCAAPOther
Written CCAAP, conventional management for patients with asthma, remind them take controller and reliever when asthma symptoms get worse.
| Study group | Role | What they receive |
|---|---|---|
| App-based CCAAP | Other | Patients in this group will be provided App-based CCAAP to remind them take medicine regularly and direct them what to do when asthma get worse. Receives: Other: App-based CCAAP |
| written CCAAP | Other | Patients in this group will be provided written asthma action plan and direct them what to do when asthma get worse. Receives: Other: Written CCAAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of asthma exacerbation
unscheduled clinics, emergency visiting, hospitalization, absent of school
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start25 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Other
- 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
- Capital Institute of Pediatrics, China, Centers for Disease Control and Prevention, China
- Responsible party
- Principal investigator, Kunling Shen, Beijing Children's Hospital
- Investigators
- Maigeng Zhou, Principal investigator, Center of Diseases Control and Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112405
- Sponsor's protocol ID
- BeijingChildrens
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of App-based Management of Children's Asthma Based on Real World Data and Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06112405
- Acronym / sponsor ID
- BeijingChildrens
- Conditions
- Asthma
- Keywords
- asthma, children, action plan, App-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Collaborators
- Capital Institute of Pediatrics, China, Centers for Disease Control and Prevention, China
- Study start
- 25 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Nov 2023 (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 compare the App-based efficacy of China Children Asthma Action Plan (CCAAP) and written CCAAP used in management of children with asthma. The main questions are:1. Is the App-based CCAAP effective/feasible in management of children with asthma? 2. Is the App-based CCAAP better than written CCAAP in management of children with asthma?
Detailed description
The study is a multi-center randomized control study.The enrollment period is 3 months. Patients who is in 6-17 years of age will be randomized recruited into two groups: the App-based asthma action plan group and the written CCAAP group. Patients in App 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 written CCAAP 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 400 cases for each group from ten children's hospitals. The study will be completed in a year.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-based CCAAP | Other | Other: App-based CCAAPPatients in this group will be provided App-based CCAAP to remind them take medicine regularly and direct them what to do when asthma get worse. |
| written CCAAP | Other | Other: Written CCAAPPatients in this group will be provided written asthma action plan and direct them what to do when asthma get worse. |
Who may qualify
- Ages
- 6 to 17 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 well 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 |
|---|---|---|
| App-based CCAAPApp-based CCAAP, could remind patients take controller and reliever when asthma symptoms get worse through mobile. | Other | App-based CCAAP |
| Written CCAAPWritten CCAAP, conventional management for patients with asthma, remind them take controller and reliever when asthma symptoms get worse. | Other | written CCAAP |
Primary outcome
number of asthma exacerbation
Time frame: 12 months
unscheduled clinics, emergency visiting, hospitalization, absent of school
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Maigeng Zhou principal investigator
Center of Diseases Control and Prevention, China
Questions about this trial
What is this clinical trial studying?
A study testing App-based CCAAP and Written CCAAP in people with Asthma, 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 1 Nov 2023. 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 Ju Yin (8613366970559, yinjucw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of asthma exacerbation (time frame: 12 months). 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 1 Nov 2023.