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Personalised Outcomes in Children With Recurrent Wheeze

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858010
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Asthma in Children Diagnostic Test: Wheeze and me questionnaire

Detailed Description:

The validation of the tool will take place at St Mary's Hospital.

The questionnaire aims to measure

  1. incidence of wheeze attacks and use of rescue medications
  2. parental/caregiver perception of recurrent wheeze control
  3. 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
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validation of a Patient-reported Outcome Measurement Tool
Estimated Study Start Date : September 11, 2020
Estimated Primary Completion Date : March 5, 2021
Estimated Study Completion Date : March 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Wheeze and me questionnaire
    validation of questionnaire assessing disease control and quality of life in preschool children with recurrent wheeze

Outcome Measures
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Primary Outcome Measures :
  1. feasibility of preschool wheeze assessment tool [ Time Frame: March 2019 - March 2020 ]
    how easily the questionnaire can be completed

  2. 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


Secondary Outcome Measures :
  1. reduction of avoidable emergency department admissions [ Time Frame: March 2020-March 2021 ]
    effect of the tool on number of avoidable emergency department presentations


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03858010


Contacts
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Contact: Heidi Makrinioti 07771348633 heidimakrinioti@gmail.com

Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Mando Watson Imperial College Healthcare NHS Trust
More Information
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Publications:

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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT03858010    
Other Study ID Numbers: 226984
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data will be anonymised and when anonymised can then be used by other researchers in the team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College Healthcare NHS Trust:
asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases