Asthma in ChildrenNCT03858010
Personalised Outcomes in Children With Recurrent Wheeze
An observational study of Asthma in Children, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
This project aims to develop a PROM for preschool children with recurrent wheeze. Nearly one third of children will have at least one episode of wheeze in the first five years of life. The majority of these children grow out of the condition in early school years. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Wheeze and me questionnaire
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2021to 5 Jun 2022
- Phase
- Observational
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total number of 350 parents of preschool children with recurrent wheeze will complete a questionnaire that assesses disease control and quality of life
Who may be able to join
- In this study caregivers of preschool children presenting with the second or more episode of wheeze that requires physician review with or without treatment (as per BTS definition of wheeze attack in preschool years) will be included.
Who cannot join
- This study will exclude caregivers who do not consent to complete the questionnaire and therefore participate in the study.
- This study will exclude caregivers of preschool children who present with their first episode of wheeze.
- This study will exclude caregivers of preschool children who present with respiratory distress of any other etiology (foreign body inhalation, croup, lower respiratory tract infection, bronchiectasis, exacerbation of cystic fibrosis or ciliopathy)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Mary's Hospital
London, W2 1NY
ChaidoNiki Makrynioti, PhD
About this study
Official title: Validation of a Patient-reported Outcome Measurement Tool
This project aims to develop a PROM for preschool children with recurrent wheeze. Nearly one third of children will have at least one episode of wheeze in the first five years of life. The majority of these children grow out of the condition in early school years. However, their families go through challenging times often with numerous emergency department admissions and hospitalizations. Hospital admission rates for preschool children with wheeze attacks remain high and are increasing in the UK. New treatments have become available, but although current treatments speed recovery from a wheeze attack, still many children visit hospitals for rescue medications and medical reviews. Recent Australian data show that one fourth of these children remain at emergency departments for a less than four hours period, suggesting that with better information and education, these children could have remained at home.
Justification-Significance of the work By understanding what really matters for these families, clinicians and stakeholders will be better able to design interventions that will reduce the hospital attendances and admissions by empowering parents to manage their children's condition. More specifically, this tool will assist GPs identify which of these children need to be reviewed by specialists, aid holistic management, ensure interventions are meaningful for families and assess the benefits of novel treatments.
Methodology The items of the questionnaire have been generated through discussions with families in a qualitative research study conducted by the research team. These items will be refined and the questionnaire will be tested with families in different healthcare settings. Researchers will assess how well this questionnaire is identifying the children who present with greater number of hospital admissions and will be benefited from suggested interventions. The data will be analysed and based on the results, amendments will be made to the questionnaire, which can will then be introduced in the routine management of these children.
Read the detailed description
The validation of the tool will take place at St Mary's Hospital.
The questionnaire aims to measure
- incidence of wheeze attacks and use of rescue medications
- parental/caregiver perception of recurrent wheeze control
- parental/caregiver perception of effect of recurrent wheeze on family/child quality of life
Participants will be given the questionnaire at the emergency departments or outpatients clinics following having consented to the study and will be asked to fill in the questionnaire and return it to their clinician.
- Conditions
- Asthma in Children
- Being tested
- Wheeze and me questionnaire
- Keywords
- asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheeze and me questionnaireDiagnostic test
validation of questionnaire assessing disease control and quality of life in preschool children with recurrent wheeze
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of preschool wheeze assessment tool
how easily the questionnaire can be completed
Measured: March 2019 - March 2020
content validity of the questionnaire
assessing validity of each item of the questionnaire as comparing with item of already existing questionnaire
Measured: March 2019-March 2020
Secondary outcomes (1)
reduction of avoidable emergency department admissions
effect of the tool on number of avoidable emergency department presentations
Measured: March 2020-March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start13 Aug 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion5 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mando Watson, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858010
- Sponsor's protocol ID
- 226984
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2019
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will be anonymised and when anonymised can then be used by other researchers in the team
Publications
Makrinioti H, Klaber R, Watson M. Around the world: preschool wheeze. Lancet Respir Med. 2017 Sep;5(9):688-689. doi: 10.1016/S2213-2600(17)30314-4. No abstract available.
PubMed 28853398
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Patient-reported Outcome Measurement Tool
- ClinicalTrials.gov ID
- NCT03858010
- Acronym / sponsor ID
- 226984
- Conditions
- Asthma in Children
- Keywords
- asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 5 Jun 2022 (estimated)
- First posted
- 28 Feb 2019 (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 project aims to develop a PROM for preschool children with recurrent wheeze. Nearly one third of children will have at least one episode of wheeze in the first five years of life. The majority of these children grow out of the condition in early school years. However, their families go through challenging times often with numerous emergency department admissions and hospitalizations. Hospital admission rates for preschool children with wheeze attacks remain high and are increasing in the UK. New treatments have become available, but although current treatments speed recovery from a wheeze attack, still many children visit hospitals for rescue medications and medical reviews. Recent Australian data show that one fourth of these children remain at emergency departments for a less than four hours period, suggesting that with better information and education, these children could have remained at home.
Justification-Significance of the work By understanding what really matters for these families, clinicians and stakeholders will be better able to design interventions that will reduce the hospital attendances and admissions by empowering parents to manage their children's condition. More specifically, this tool will assist GPs identify which of these children need to be reviewed by specialists, aid holistic management, ensure interventions are meaningful for families and assess the benefits of novel treatments.
Methodology The items of the questionnaire have been generated through discussions with families in a qualitative research study conducted by the research team. These items will be refined and the questionnaire will be tested with families in different healthcare settings. Researchers will assess how well this questionnaire is identifying the children who present with greater number of hospital admissions and will be benefited from suggested interventions. The data will be analysed and based on the results, amendments will be made to the questionnaire, which can will then be introduced in the routine management of these children.
Detailed description
The validation of the tool will take place at St Mary's Hospital.
The questionnaire aims to measure
- incidence of wheeze attacks and use of rescue medications
- parental/caregiver perception of recurrent wheeze control
- parental/caregiver perception of effect of recurrent wheeze on family/child quality of life
Participants will be given the questionnaire at the emergency departments or outpatients clinics following having consented to the study and will be asked to fill in the questionnaire and return it to their clinician.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total number of 350 parents of preschool children with recurrent wheeze will complete a questionnaire that assesses disease control and quality of life
Key inclusion criteria (1 listed)
- In this study caregivers of preschool children presenting with the second or more episode of wheeze that requires physician review with or without treatment (as per BTS definition of wheeze attack in preschool years) will be included.
Key exclusion criteria (3 listed)
- This study will exclude caregivers who do not consent to complete the questionnaire and therefore participate in the study.
- This study will exclude caregivers of preschool children who present with their first episode of wheeze.
- This study will exclude caregivers of preschool children who present with respiratory distress of any other etiology (foreign body inhalation, croup, lower respiratory tract infection, bronchiectasis, exacerbation of cystic fibrosis or ciliopathy)
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 |
|---|---|---|
| Wheeze and me questionnairevalidation of questionnaire assessing disease control and quality of life in preschool children with recurrent wheeze | Diagnostic test | – |
Primary outcome
feasibility of preschool wheeze assessment tool
Time frame: March 2019 - March 2020
how easily the questionnaire can be completed
content validity of the questionnaire
Time frame: March 2019-March 2020
assessing validity of each item of the questionnaire as comparing with item of already existing questionnaire
1 secondary outcome
reduction of avoidable emergency department admissions
Time frame: March 2020-March 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Background: PubMed 28853398Makrinioti H, Klaber R, Watson M. Around the world: preschool wheeze. Lancet Respir Med. 2017 Sep;5(9):688-689. doi: 10.1016/S2213-2600(17)30314-4. No abstract available.
- Individual participant dataSharing planned: No. individual participant data will be anonymised and when anonymised can then be used by other researchers in the team
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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.
Mando Watson principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 3 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 21 Mar 2022. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Makrinioti (07771348633, heidimakrinioti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of preschool wheeze assessment tool (time frame: March 2019 - March 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858010, which also lists 1 linked publication.
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 21 Mar 2022.