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ISRCTN
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ISRCTN13912429
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ClinicalTrials.gov identifier
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Public title
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Children's Health in Asthma: Research to Improve Status through Modifying Accommodation
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Scientific title
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Acronym
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CHARISMA
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Serial number at source
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N/A
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Study hypothesis
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The aim of the study is to evaluate the effectiveness and cost-effectiveness of improving ventilation in heating in the homes of children with moderate or severe asthma who live within Wrexham.
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Ethics approval
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North East Wales Local Research Committee approved of the trial on the 30th July 2003.
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Study design
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Pragmatic randomised controlled trial with delayed-implementation controls.
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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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Moderate or severe asthma in children
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Participants - inclusion criteria
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1. Children aged 5 - 15 at recruitment
2. Living in Wrexham County Borough Council
3. On list of participating general practice
4. Ttaking inhaled steroids for asthma (three or more prescriptions over a 12 month period)
5. Written consent from parent or guardian to take part, complete questionnaires, and allow access to childs medical records
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Participants - exclusion criteria
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1. Cystic fibrosis
2. Likely to move of the Wrexham County Borough Council area within 12 months
3. Ventilation system already installed and central heating already aequate at pre-randomisation base line
Where a household contains two or more eligible children, one participant is chosen at random as the index case for whom outcomes are assessed.
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Anticipated start date
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01/09/2003
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Anticipated end date
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01/05/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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200
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Interventions
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Pragmatic randomised controlled trial with delayed-implementation controls: analysis by intention to treat. Patients are identified from GP records. Remote randomisation is stratified by GP practice, whether central heating needs improving, childs age and gender, type of housing, and household smoking status.
A package of housing improvements designed to provide adequate ventilation and temperatures and to reduce mould spores:
1. If the recruited child has one or more siblings who suffer from asthma and sleep in a different room, the housing department install a whole-house ventilation system. Otherwise they install a single-room ventilation unit
2. Improvements to bring central heating to a defined standard, if required
The control group are offered the same installation package 12 months later, after the final follow-up questionnaire has been returned.
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Primary outcome measure(s)
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Parental assessment of the child's asthma-specific quality of life (PedQL asthma module) four and twelve months after randomisation. Baseline PedQL will be used as a covariate.
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Secondary outcome measure(s)
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1. General health-related quality of life (PedQL core module), school attendance and the use of health care including medication
2. An economic analysis will compare costs
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Sources of funding
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1. North Wales Research Committee (UK)
2. Npower-Health Through Wales (UK)
3. Wrexham County Borough Council (UK)
4. Wrexham Local Health Alliance (UK)
5. Local Health Board, National Public Health Service for Wales (UK)
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Trial website
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Publications
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Contact name
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Prof
Ian
Russell
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Address
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University of Wales Bangor
Brigantia Building
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City/town
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Bangor
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Zip/Postcode
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LL57
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Country
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United Kingdom
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Tel
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+44 (0)1248 383002
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Email
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ian.russell@bangor.ac.uk
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Sponsor
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University of Wales Bangor (UK)
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Address
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IMSCaR
Ardudwy
Normal Site
Holyhead Road
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City/town
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Bangor
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Zip/Postcode
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LL57 2PX
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Country
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United Kingdom
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Tel
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+44 (0)1248 388095
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Email
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ian.russell@bangor.ac.uk
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Sponsor website:
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http://www.bangor.ac.uk/home/2006/index.php.en?&width=1024&height=768
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Date applied
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09/03/2007
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Last edited
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19/07/2007
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Date ISRCTN assigned
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19/07/2007
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