Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases (NCT02229994) | Clinical Trial Compass
CompletedNot Applicable
Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases
France199 participantsStarted 2010-03-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
What they're measuring
1
Psychometric validity of the questionnaire
Timeframe: Until end of treatment (making a total of 6 months)