Children's Health in Asthma: Research to Improve Status through Modifying Accommodation
| ISRCTN | ISRCTN13912429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13912429 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/03/2007
- Registration date
- 19/07/2007
- Last edited
- 14/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ian Russell
Scientific
Scientific
University of Wales Bangor
Brigantia Building
Bangor
LL57 2AS
United Kingdom
| Phone | +44 (0)1248 383002 |
|---|---|
| ian.russell@bangor.ac.uk |
Study information
| Study design | Pragmatic randomised controlled trial with delayed-implementation controls. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | CHARISMA |
| Study objectives | 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. |
| Ethics approval(s) | North East Wales Local Research Committee approved of the trial on the 30th July 2003. |
| Health condition(s) or problem(s) studied | Moderate or severe asthma in children |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/09/2003 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 15 Years |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
University of Wales Bangor
Bangor
LL57 2AS
United Kingdom
LL57 2AS
United Kingdom
Sponsor information
University of Wales Bangor (UK)
University/education
University/education
IMSCaR
Ardudwy
Normal Site
Holyhead Road
Bangor
LL57 2PX
Wales
United Kingdom
| Phone | +44 (0)1248 388095 |
|---|---|
| ian.russell@bangor.ac.uk | |
| Website | http://www.bangor.ac.uk/home/2006/index.php.en?&width=1024&height=768 |
"ROR" |
https://ror.org/006jb1a24 |
Funders
Funder type
Government
North Wales Research Committee (UK)
No information available
Npower-Health Through Wales (UK)
No information available
Wrexham County Borough Council (UK)
No information available
Wrexham Local Health Alliance (UK)
No information available
Local Health Board, National Public Health Service for Wales (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | cost-effectiveness results | 01/11/2011 | Yes | No | |
| Results article | results | 01/11/2011 | Yes | No |
