Personalised Outcomes in Children With Recurrent Wheeze

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Heidi Makrinioti; Phone Number: 07771348633; Email: heidimakrinioti@gmail.com

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1NY
    • Recruiting
    • St Mary's Hospital
    • Contact: ChaidoNiki Makrynioti, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction of avoidable emergency department admissions	effect of the tool on number of avoidable emergency department presentations	March 2020-March 2021

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Investigators: Principal Investigator: Mando Watson, Imperial College Healthcare NHS Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 5, 2022

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 226984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data will be anonymised and when anonymised can then be used by other researchers in the team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No