National Validation and Sensitivity to Change of a Scale to Measure Quality of Life in Patients With Severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 410
- 试验地点
- 5
- 主要终点
- Change in Severe Asthma Questionnaire (SAQ) score
研究概览
简要总结
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:
- The Severe Asthma Questionnaire (SAQ)
- The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
- The EQ-5D-5L
- The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Severe Asthma Questionnaire (SAQ) score
时间窗: Part 2: Sensitivity to change: Collected at 0 (baseline) 4, 8, 12 & 16 weeks, (enrollment period of 10 months)
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.
Severe Asthma Questionnaire (SAQ) score
时间窗: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months)
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.
次要结局
- 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)
- 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 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)
- 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))
- 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)