NCT04031261

National Validation and Sensitivity to Change of the SAQ

National Validation and Sensitivity to Change of a Scale to Measure Quality of Life in Patients With Severe Asthma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 410 (actual)
• Sponsor: University Hospital Plymouth NHS Trust · Academic / Other
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthma
• Severe Asthma

Timeline

• Start date: 2019-04-10
• Primary completion: 2020-03-23
• Completion: 2020-03-23
• First posted: 2019-07-24
• Last updated: 2021-01-06

Locations

5 sites across 1 country: United Kingdom