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ISRCTN
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ISRCTN57801413
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ClinicalTrials.gov identifier
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Public title
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Development and validation of a caregiver quality of life questionnaire for wheezy preschool children
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Scientific title
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Acronym
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QOL
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Serial number at source
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7819
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Study hypothesis
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To establish a valid and reliable measure of health-related quality of life for caregivers of wheezy preschool children.
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Lay summary
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Ethics approval
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Kent Research Ethics Committee approved in July 2006 (ref: 06/Q1905/8)
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Study design
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Single centre non-randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory
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Participants - inclusion criteria
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1. Boys and girls
2. History of 2 or more wheezing episodes
3. Age 1 year to 5 years 11 months
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Participants - exclusion criteria
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Other major medical problem
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Anticipated start date
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01/01/2010
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 210
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Interventions
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Item reduction stage:
Asking carers of wheezy preschool children to complete a quality of life (QOL) questionnaire plus two data sheets. It takes about half an hour to complete the questionnaire.
Validation stage:
The final questionnaire will be given to parents to complete on three occasions (over approximately 8 weeks):
1. At first clinic visit
2. 1 - 2 weeks later before any change in treatment has been made
3. 6 weeks after a change in asthma treatment intended to bring the asthma symptoms under control
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Primary outcome measure(s)
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To have a validated quality of life questionnaire for caregivers of wheezy preschool children
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Asthma UK (UK)
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Trial website
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Publications
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Contact name
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Ms
Catherine
Olden
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Address
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Respiratory Care
Royal Sussex County Hospital
Eastern Road
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City/town
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Brighton
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Zip/Postcode
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BN2 5BE
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Country
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United Kingdom
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Email
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catherine.olden@bsuh.nhs.uk
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Sponsor
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Brighton and Sussex University Hospitals NHS Trust (UK)
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Address
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Royal Sussex County Hospital
Eastern Road
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City/town
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Brighton
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Zip/Postcode
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BN2 5BE
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Country
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United Kingdom
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Sponsor website:
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http://www.bsuh.nhs.uk/
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Date applied
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24/06/2010
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Last edited
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20/10/2010
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Date ISRCTN assigned
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24/06/2010
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