Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Psychometric validity of the questionnaire
研究概览
简要总结
The purpose of this study is the psychometric validation of a self-administered dyspnea questionnaire, usable in clinical practice in order to assess dyspnea and its impact on patients with chronic respiratory diseases.
详细描述
Dyspnea is a cardinal Respiratory symptom.
According to the ATS dyspnea is the term used to characterize a subjective experience of breathing discomfort, covering qualitatively distinct sensations of varying intensity.
The subjective nature of dyspnea and the high complexity of its determinants explain the often moderate correlations obtained with physiological data. Dyspnea must therefore be measured specifically.
The aim of this study is the cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire (assessing the impact of dyspnea on activities restriction), usable in clinical practice in order to assess dyspnea and its alterations in adult patients with chronic respiratory diseases.
(COPD, diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Sample1: COPD GOLD / ATS > 2 without major co-morbidity
- •Sample 1A: n = 50: group of patients with no change in usual care and no acute event (evaluation of reproducibility)
- •Sample1B: n = 60: patients assessed before and after a qualifying period of pulmonary rehabilitation
- •2) Sample 2 (n = 30): diffuse interstitial lung diseases Criteria: Pulmonary Fibrosis: Idiopathic or nonspecific interstitial lung diseases (NILD) according to international criteria (ATS), sarcoidosis with parenchymal lesions (old classification stage II and III), and exceptionally alveolar proteinosis.
- •3) Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post embolic .....).
- •4) Sample4 (n = 30): Adult with Cystic fibrosis.
- •5) patient with stable Status (no exacerbation for at least one month)
排除标准
- •1) Patient under 18 years
- •2) Inability to fill in questionnaires
- •3) Other respiratory disease
- •4) left symptomatic heart failure
- •5) Obesity with a BMI> 35 kg/m2
- •6) Inability to perform PFT (Pulmonary Function Testing)
- •7) Pregnant or breastfeeding woman
- •8) Patient unable to consent
- •9) Lack of social insurance coverage
- •10) Patient in exclusion period because of another protocol
结局指标
主要结局
Psychometric validity of the questionnaire
时间窗: Until end of treatment (making a total of 6 months)
Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire
次要结局
- Structural analysis (in principal components)(Until end of treatment (making a total of 6 months))
- Analysis of responses distribution(Until end of treatment (making a total of 6 months))
- External and convergent validity(Until end of treatment (making a total of 6 months))
- Internal coherence(Until end of treatment (making a total of 6 months))
- Reproducibility(7 days)
- Discriminating properties(Until end of treatment (making a total of 6 months))
- Derivation of a scoring algorithm(Until end of treatment (making a total of 6 months))
- Sensitivity to change(Until end of treatment (making a total of 6 months))
- Minimal difference clinically relevant(Until end of treatment (making a total of 6 months))