Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-02-22 @ 2:46 PM
Study NCT ID:
NCT04031261
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2019-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Validation and Sensitivity to Change of the SAQ
Sponsor:
University Hospital Plymouth NHS Trust
Organization:
Study Overview
Official Title:
National Validation and Sensitivity to Change of a Scale to Measure Quality of Life in Patients With Severe Asthma
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
DESIGN A multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data.
AIMS To collect further quantitative data to validate a new asthma quality of life scale, the Severe Asthma Questionnaire (SAQ).
To determine the Minimum Clinically Important Difference (MCID) of the SAQ
OUTCOME MEASURES
Questionnaires:
1. The Severe Asthma Questionnaire (SAQ)
2. The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
3. The EQ-5D-5L
4. The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)
5. Global Rating of Change Questionnaire (GRCQ)
Clinical data comprises:
6. Spirometry
7. BMI
8. Asthma severity
9. Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the last 12 months;
10. Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if oral steroid dependent).
POPULATION All patients aged 16 years or over, who have attended one of three participating UK specialist asthma centres for the validation study and with data also collected from Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important difference.
ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma
DURATION 18 months
AIMS To collect further quantitative data to validate a new asthma quality of life scale, the Severe Asthma Questionnaire (SAQ).
To determine the Minimum Clinically Important Difference (MCID) of the SAQ
OUTCOME MEASURES
Questionnaires:
1. The Severe Asthma Questionnaire (SAQ)
2. The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
3. The EQ-5D-5L
4. The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)
5. Global Rating of Change Questionnaire (GRCQ)
Clinical data comprises:
6. Spirometry
7. BMI
8. Asthma severity
9. Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the last 12 months;
10. Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if oral steroid dependent).
POPULATION All patients aged 16 years or over, who have attended one of three participating UK specialist asthma centres for the validation study and with data also collected from Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important difference.
ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma
DURATION 18 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: