COPD (With - Without Rehabilitation) Clinical Trial
— DYSLIMOfficial title:
Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases
Verified date | July 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 199 |
Est. completion date | December 30, 2015 |
Est. primary completion date | March 27, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychometric validity of the questionnaire | Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) | |
Secondary | Analysis of responses distribution | Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) | |
Secondary | Structural analysis (in principal components) | Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) | |
Secondary | External and convergent validity | Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) | |
Secondary | Internal coherence | Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) | |
Secondary | Reproducibility | Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) | |
Secondary | Reproducibility | for a sub sample of 50 patients, Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire | 7 days | |
Secondary | Discriminating properties | Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) | |
Secondary | Derivation of a scoring algorithm | Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) | |
Secondary | Sensitivity to change | Sensitivity to change will be analyzed in relation to: The TDI score, at the Likert scale on changes in dyspnea The scores of quality of life with their respective significant thresholds A the overall medical evaluation A changing EFR parameters with their respective significant thresholds (FEV, DLCO, walk test .....). All this are the transversal data necessaries to assess the validation of a psychometric self-administered dyspnea questionnaire. |
Until end of treatment (making a total of 6 months) | |
Secondary | Minimal difference clinically relevant | Cross-sectional data necessary to assess the psychometric validity of a self-administered dyspnea questionnaire | Until end of treatment (making a total of 6 months) |