| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN13912429 |
| Date ISRCTN assigned | 19/07/2007 |
| Local reference number(s) | N/A |
| Public title | Children's Health in Asthma: Research to Improve Status through Modifying Accommodation |
| Scientific title |
|
| Acronym | CHARISMA |
| Disease/condition/study domain | Moderate or severe asthma in children |
| Study hypothesis | 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. |
| Design/methodology | Pragmatic randomised controlled trial with delayed-implementation controls. |
| Research ethics review | North East Wales Local Research Committee approved of the trial on the 30th July 2003. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | 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. |
| Patient information material |
|
| Anticipated start date | 01/09/2003 |
| Anticipated end date | 01/05/2007 |
| Status of trial | Completed |
| Target number of participants | 200 |
| Interventions | 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. |
| Primary outcome measure(s) | 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. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | 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) |
| Sponsor name | University of Wales Bangor (UK) |
| Sponsor details | IMSCaR
Ardudwy
Normal Site
Holyhead Road
Bangor
United Kingdom
LL57 2PX |
| Sponsor telephone | +44 (0)1248 388095 |
| Sponsor email | ian.russell@bangor.ac.uk |
| Sponsor website | http://www.bangor.ac.uk/home/2006/index.php.en?&width=1024&height=768 |
| Contact name | Prof Ian Russell |
| Contact details | University of Wales Bangor
Brigantia Building
Bangor
United Kingdom
LL57 |
| Contact telephone | +44 (0)1248 383002 |
| Contact email | ian.russell@bangor.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN13912429 |
| Date last extracted from ISRCTN register | 17/04/2008 |
