Personalised Outcomes in Children With Recurrent Wheeze
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|ClinicalTrials.gov Identifier: NCT03858010|
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : July 30, 2020
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|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
- Diagnostic Test: Wheeze and me questionnaire
validation of questionnaire assessing disease control and quality of life in preschool children with recurrent wheeze
- 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
- reduction of avoidable emergency department admissions [ Time Frame: March 2020-March 2021 ]effect of the tool on number of avoidable emergency department presentations
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
|Contact: Heidi Makriniotifirstname.lastname@example.org|
|Principal Investigator:||Mando Watson||Imperial College Healthcare NHS Trust|