Condition category
Respiratory
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
30/09/2016
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

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

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

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

Publication citations

Additional files

Editorial Notes

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