Condition category
Respiratory
Date applied
09/03/2007
Date assigned
19/07/2007
Last edited
14/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ian Russell

ORCID ID

Contact details

University of Wales Bangor
Brigantia Building
Bangor
LL57 2AS
United Kingdom
+44 (0)1248 383002
ian.russell@bangor.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CHARISMA

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.

Ethics approval

North East Wales Local Research Committee approved of the trial on the 30th July 2003.

Study design

Pragmatic randomised controlled trial with delayed-implementation controls.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2003

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

200

Participant 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.

Recruitment start date

01/09/2003

Recruitment end date

01/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Wales Bangor
Bangor
LL57 2AS
United Kingdom

Sponsor information

Organisation

University of Wales Bangor (UK)

Sponsor details

IMSCaR
Ardudwy
Normal Site
Holyhead Road
Bangor
LL57 2PX
United Kingdom
+44 (0)1248 388095
ian.russell@bangor.ac.uk

Sponsor type

University/education

Website

http://www.bangor.ac.uk/home/2006/index.php.en?&width=1024&height=768

Funders

Funder type

Government

Funder name

North Wales Research Committee (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Npower-Health Through Wales (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Wrexham County Borough Council (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Wrexham Local Health Alliance (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Local Health Board, National Public Health Service for Wales (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22054336
2. 2011 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/22054337

Publication citations

  1. Results

    Woodfine L, Neal RD, Bruce N, Edwards RT, Linck P, Mullock L, Nelhans N, Pasterfield D, Russell D, Russell I, Enhancing ventilation in homes of children with asthma: pragmatic randomised controlled trial., Br J Gen Pract, 2011, 61, 592, e724-32, doi: 10.3399/bjgp11X606636.

  2. Edwards RT, Neal RD, Linck P, Bruce N, Mullock L, Nelhans N, Pasterfield D, Russell D, Russell I, Woodfine L, Enhancing ventilation in homes of children with asthma: cost-effectiveness study alongside randomised controlled trial., Br J Gen Pract, 2011, 61, 592, e733-41, doi: 10.3399/bjgp11X606645.

Additional files

Editorial Notes