Clinical trial NCT04031261: National Validation and Sensitivity to Change of the SAQ
Official title: National Validation and Sensitivity to Change of a Scale to Measure Quality of Life in Patients With Severe Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Severe Asthma
Keywords: Quality of Life
Patient Reported Outcomes
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Plymouth
First posted: 2019-07-24
Enrollment: 410
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over.

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


Eligibility criteria: Part 1: National Validation

Inclusion Criteria:

* All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over.

Exclusion Criteria:

* Patients that are unwilling to participate will be excluded from the study.
* In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma, which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe Chronic Obstructive Pulmonary Disease (COPD).
* The SAQ is currently only translated into British English. Therefore, if the participant is unable to read in English, they will be unable to participate.

Part 2: Sensitivity to change

Inclusion Criteria

* Patients commencing a biologic treatment for their severe asthma (GINA step 4 \& 5), as per NICE guidelines.

Exclusion Criteria

* Patients will be excluded from the study if they are unwilling to participate
* In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe COPD.

Primary outcomes:
measure: Severe Asthma Questionnaire (SAQ) score
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months)
measure: Change in Severe Asthma Questionnaire (SAQ) score
timeFrame: Part 2: Sensitivity to change: Collected at 0 (baseline) 4, 8, 12 & 16 weeks, (enrollment period of 10 months)
Secondary outcomes:
measure: The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
timeFrame: Part 1: National Validation & Part 2: Sensitivity to change - Collected at 0 (baseline) weeks, within two weeks after enrollment (enrollment period of 6 or 10 months respectively)
measure: Asthma Control Test (ACT)
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months), Part 2: Sensitivity to change - Collected at 0 (baseline) 4, 8, 12 & 16 weeks
measure: Asthma Control Questionnaire (ACQ)
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline) 4, 8, 12 & 16 weeks
measure: EQ-5D-5L
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months) , Part 2: Sensitivity to change - Collected at 0 (baseline) & 16 weeks within 2 weeks of enrollment
measure: Change in Global Rating of Change Questionnaire (GRCQ)
timeFrame: Part 2: Sensitivity to change - Collected at 4, 8, 12 & 16 weeks within 2 weeks of enrollment (enrollment period of 10 months)
Other outcomes:
measure: Forced Expiatory Volume in One Second (FEV1)
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline) & 16 weeks
measure: Percentage of predicted FEV1 (FEV1%)
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline) & 16 weeks
measure: Body Mass Index (BMI)
timeFrame: Part 1: National Validation & Part 2: Sensitivity to change - Collected at 0 (baseline) weeks, within two weeks after enrollment (enrollment period of 6 or 10 months respectively)
measure: Maintenance Oral Corticosteroid dose (mg/day)
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline) 4, 8, 12 & 16 weeks
measure: Number of exacerbation in the last 12 months requiring OCS
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline). Additional exacerbation since baseline recorded at 4, 8, 12 & 16 weeks
measure: Number of Emergency Department attendances in the last 12 months
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline). Additional ED visits 0 since baseline recorded at 4, 8, 12 & 16 weeks
measure: Number Hospital admissions in the last 12 months
timeFrame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline). Additional Hospital admissions since baseline recorded at 4, 8, 12 & 16 weeks
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital - Manchester
city: Plymouth
country: United Kingdom
facility: University Hopsitals Plymouth NHS Trust
Study officials:
References: