Asthmatic AttackAIREdNCT02948738
Asthma Inpatient Research on Education
A study testing Interactive Asthma Education and Standard Asthma Education in people with Asthmatic Attack, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
Children with asthma are admitted for asthma attacks very frequently in the U.S. The families and children are given basic education about asthma but studies are needed to improve this education so that it makes a meaningful difference in health outcomes and asthma care. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Asthmatic Attack
- What is being tested?
- Interactive Asthma Education and Standard Asthma Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Dec 2018
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of asthma
Who cannot join
- Active Cardiac Disease
- Speaks language other than English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann and Robert H. Lurie Childrens Hosptial of Chicago
Chicago, Illinois, 60611
About this study
Official title: Asthma Inpatient Research on Education: A Randomized Clinical Trial
Children with asthma are admitted for asthma attacks very frequently in the U.S. The families and children are given basic education about asthma but studies are needed to improve this education so that it makes a meaningful difference in health outcomes and asthma care. This study compares two inpatient education models for children hospitalized with asthma.
Read the detailed description
The current standard is to review an asthma action plan with families and to review inhaler medication administration. In this study, investigators will be assigning families to either a control (current standard education) or and intervention group. In the intervention group, participants will receive interactive education based on learning theories that are thought to enhance long term memory. Participants in the interactive group will build their own action plan using colored templates and pictures. Participants will also learn to use their inhaler using teach-back methodologies. Investigators will then compare the two groups in terms of ER visits, hospitalizations, family confidence in managing asthma, asthma knowledge, and quality of life.
- Conditions
- Asthmatic Attack
- Being tested
- Interactive Asthma Education, Standard Asthma Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Asthma EducationBehavioural
Active participation to develop asthma action plan and teach back cycles for asthma inhaler teaching/training
Standard Asthma EducationBehavioural
Basic review of asthma action plan and inhaler use
| Study group | Role | What they receive |
|---|---|---|
| Interactive Education | Experimental | Interactive asthma education Receives: Behavioral: Interactive Asthma Education |
| Standard Education | Active comparator | Standard asthma education Receives: Behavioral: Standard Asthma Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
ER visits
Number of ER visits in the year after education
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 posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthmatic AttackStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waheeda Samady, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Waheeda Samady, MD, Principal investigator, Northwestern University and Lurie Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948738
- Sponsor's protocol ID
- ChildrensMemorialH
- Acronym
- AIREd
- Status last verified
- Feb 2019
- First submitted
- 27 Oct 2016
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Inpatient Research on Education: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02948738
- Acronym / sponsor ID
- AIREd / ChildrensMemorialH
- Conditions
- Asthmatic Attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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.
Children with asthma are admitted for asthma attacks very frequently in the U.S. The families and children are given basic education about asthma but studies are needed to improve this education so that it makes a meaningful difference in health outcomes and asthma care. This study compares two inpatient education models for children hospitalized with asthma.
Detailed description
The current standard is to review an asthma action plan with families and to review inhaler medication administration. In this study, investigators will be assigning families to either a control (current standard education) or and intervention group. In the intervention group, participants will receive interactive education based on learning theories that are thought to enhance long term memory. Participants in the interactive group will build their own action plan using colored templates and pictures. Participants will also learn to use their inhaler using teach-back methodologies. Investigators will then compare the two groups in terms of ER visits, hospitalizations, family confidence in managing asthma, asthma knowledge, and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Education | Experimental | Behavioral: Interactive Asthma EducationInteractive asthma education |
| Standard Education | Active comparator | Behavioral: Standard Asthma EducationStandard asthma education |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of asthma
Key exclusion criteria (2 listed)
- Active Cardiac Disease
- Speaks language other than English or Spanish
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 |
|---|---|---|
| Interactive Asthma EducationActive participation to develop asthma action plan and teach back cycles for asthma inhaler teaching/training | Behavioural | Interactive Education |
| Standard Asthma EducationBasic review of asthma action plan and inhaler use | Behavioural | Standard Education |
Primary outcome
ER visits
Time frame: 1 year
Number of ER visits in the year after education
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Asthmatic Attack
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingObservational study
Remote Monitoring of Asthma in Children and Young People
Asthma Childhood, Asthma Attack
RecruitingPhase 2
Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
Asthma Acute, Asthma Attack
Recruiting
Post Exacerbation Asthma Clinic Telecare Intervention to Reduce Recurrent Exacerbations
Asthma Acute, Asthma Attack
Recruiting
Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation
Asthma Attack, Asthma Control
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.
Waheeda Samady, MD principal investigator
Northwestern University and Lurie Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Asthma Education and Standard Asthma Education in people with Asthmatic Attack, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ER visits (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 6 Feb 2019.