National Validation and Sensitivity to Change of the SAQ

NCT04031261 | Completed

• 1 other identifier: 18/P/089
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 5

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. 1.The Severe Asthma Questionnaire (SAQ)
2. 2.The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
3. 3.The EQ-5D-5L
4. 4.The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)
5. 5.Global Rating of Change Questionnaire (GRCQ)
6. 6.Spirometry
7. 7.BMI
8. 8.Asthma severity
9. 9.Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the last 12 months;
10. 10.Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if oral steroid dependent).

Conditions

Asthma; Severe Asthma

Keywords

Quality of Life; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (2)

• Severe Asthma Questionnaire (SAQ) score

  The new questionnaire will provide a combined assessment of disease and its treatment on the quality of life of patients with severe asthma. The scale is based on existing Health Related Quality of Life (HRQoL) scales but modified for the severe population and provides assessments of the effect of asthma symptoms and the effect of asthma medicines. The SAQ was produced from detailed qualitative research. The questionnaire has 16 items, scored on a 1-7 scale (a higher score indicating better quality of life). The mean score of these 16 questions is calculated to produce an overall score. An additional 3 items are included to asses overall HRQoL, and HRQoL during different months of the year. These three questions are scored on a 100 point scale with a higher score indicating better HRQoL.

  Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months)

• Change in Severe Asthma Questionnaire (SAQ) score

  The Severe Asthma Questionnaire (SAQ) will be collected at 5 time points and matched with the Global Rating of Change questionnaire at these time points to determine the SAQ's Minimum Clinically Important Difference (MCID). The questionnaire has 16 items, scored on a 1-7 scale (a higher score indicating better quality of life). The mean score of these 16 questions is calculated to produce an overall score. An additional 3 items are included to asses overall HRQoL, and HRQoL during different months of the year. These three questions are scored on a 100 point scale with a higher score indicating better HRQoL.

  Part 2: Sensitivity to change: Collected at 0 (baseline) 4, 8, 12 & 16 weeks, (enrollment period of 10 months)

Secondary Outcomes (5)

• The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)

  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)

• Asthma Control Test (ACT)

  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

• Asthma Control Questionnaire (ACQ)

  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

• EQ-5D-5L

  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

• Change in Global Rating of Change Questionnaire (GRCQ)

  Part 2: Sensitivity to change - Collected at 4, 8, 12 & 16 weeks within 2 weeks of enrollment (enrollment period of 10 months)

Other Outcomes (7)

• Forced Expiatory Volume in One Second (FEV1)

  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

• Percentage of predicted FEV1 (FEV1%)

  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

• Body Mass Index (BMI)

  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)

Study Arms (2)

National Validation

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.

Sensitivity to Change

Patients commencing a biologic treatment for their severe asthma (GINA step 4 \& 5), as per National Institute for Health and Care Excellence (NICE) guidelines.

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead
• University of Plymouth: collaborator

Study Sites (5)

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Royal Devon & Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Wythenshawe Hospital - Manchester

Manchester, M23 9LT, United Kingdom

Location

University Hopsitals Plymouth NHS Trust

Plymouth, Pl4 8DH, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 24, 2019
• Study Start: April 10, 2019
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: January 6, 2021

Record last verified: 2019-06

Locations

GB (5)