Personalised Outcomes in Children With Recurrent Wheeze

NCT03858010 | Unknown

• 1 other identifier: 226984
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

asthma

Outcome Measures

Primary Outcomes (2)

• feasibility of preschool wheeze assessment tool

  how easily the questionnaire can be completed

  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

  March 2019-March 2020

Secondary Outcomes (1)

• reduction of avoidable emergency department admissions

  March 2020-March 2021

Interventions

Wheeze and me questionnaire DIAGNOSTIC_TEST

validation of questionnaire assessing disease control and quality of life in preschool children with recurrent wheeze

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

St Mary's Hospital

London, W2 1NY, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 28853398 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mando Watson

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi Makrinioti

CONTACT

07771348633; heidimakrinioti@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: August 13, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 5, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)