Contact information
Type
Scientific
Primary contact
Ms Catherine Olden
ORCID ID
Contact details
Respiratory Care
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
-
catherine.olden@bsuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7819
Study information
Scientific title
Development and validation of a caregiver quality of life questionnaire for wheezy preschool children
Acronym
QOL
Study hypothesis
To establish a valid and reliable measure of health-related quality of life for caregivers of wheezy preschool children.
Ethics approval
Kent Research Ethics Committee, July 2006, ref: 06/Q1905/8
Study design
Single centre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
To have a validated quality of life questionnaire for caregivers of wheezy preschool children
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2010
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Boys and girls
2. History of 2 or more wheezing episodes
3. Age 1 year to 5 years 11 months
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned sample size: 210
Participant exclusion criteria
Other major medical problem
Recruitment start date
01/01/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Sussex County Hospital
Brighton
BN2 5BE
United Kingdom
Sponsor information
Organisation
Brighton and Sussex University Hospitals NHS Trust (UK)
Sponsor details
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Asthma UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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