Development and validation of a caregiver quality of life questionnaire for wheezy preschool children

ISRCTN	ISRCTN57801413
DOI	https://doi.org/10.1186/ISRCTN57801413
Secondary identifying numbers	7819

Submission date: 24/06/2010
Registration date: 24/06/2010
Last edited: 30/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Catherine Olden
Scientific

Respiratory Care
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Email	catherine.olden@bsuh.nhs.uk

Study information

Study design	Single centre non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Development and validation of a caregiver quality of life questionnaire for wheezy preschool children
Study acronym	QOL
Study objectives	To establish a valid and reliable measure of health-related quality of life for caregivers of wheezy preschool children.
Ethics approval(s)	Kent Research Ethics Committee, July 2006, ref: 06/Q1905/8
Health condition(s) or problem(s) studied	Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory
Intervention	Item reduction stage: Asking carers of wheezy preschool children to complete a quality of life (QOL) questionnaire plus two data sheets. It takes about half an hour to complete the questionnaire. Validation stage: The final questionnaire will be given to parents to complete on three occasions (over approximately 8 weeks): 1. At first clinic visit 2. 1 - 2 weeks later before any change in treatment has been made 3. 6 weeks after a change in asthma treatment intended to bring the asthma symptoms under control
Intervention type	Other
Primary outcome measure	To have a validated quality of life questionnaire for caregivers of wheezy preschool children
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/01/2010
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	5 Years
Sex	Both
Target number of participants	Planned sample size: 210
Key inclusion criteria	1. Boys and girls 2. History of 2 or more wheezing episodes 3. Age 1 year to 5 years 11 months
Key exclusion criteria	Other major medical problem
Date of first enrolment	01/01/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Sussex County Hospital

Brighton
BN2 5BE
United Kingdom

Sponsor information

Brighton and Sussex University Hospitals NHS Trust (UK)
Hospital/treatment centre

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom

Website	http://www.bsuh.nhs.uk/

Funders

Funder type

Charity

Asthma UK (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): Asthma UK, Asthma + Lung UK
Location: United Kingdom

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

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator.