Children's Health in Asthma: Research to Improve Status through Modifying Accommodation
| ISRCTN | ISRCTN13912429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13912429 |
| Protocol serial number | N/A |
| Sponsor | University of Wales Bangor (UK) |
| Funders | North Wales Research Committee (UK), Npower-Health Through Wales (UK), Wrexham County Borough Council (UK), Wrexham Local Health Alliance (UK), Local Health Board, National Public Health Service for Wales (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic randomised controlled trial with delayed-implementation controls. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(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. |
| Key secondary outcome measure(s) |
1. General health-related quality of life (PedQL core module), school attendance and the use of health care including medication |
| 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 sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
