Development and validation of a caregiver quality of life questionnaire for wheezy preschool children
| ISRCTN | ISRCTN57801413 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57801413 |
| Protocol serial number | 7819 |
| Sponsor | Brighton and Sussex University Hospitals NHS Trust (UK) |
| Funder | Asthma UK (UK) |
- 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
Scientific
Respiratory Care
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
| catherine.olden@bsuh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre non-randomised interventional treatment trial |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
To have a validated quality of life questionnaire for caregivers of wheezy preschool children |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 5 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal Sussex County Hospital
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/09/2016: No publications found, verifying study status with principal investigator.
