Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases

NCT02229994 | Completed

• 1 other identifier: 2009-A00181-56
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD (With - Without Rehabilitation); Diffuse Interstitial Lung Diseases; Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....); Cystic Fibrosis of the Adult

Keywords

Dyspnea; Self-administered questionnaire; Chronic respiratory disease; COPD; Diffuse interstitial lung diseases; Pulmonary arterial hypertension; Cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Analysis of responses distribution

  Until end of treatment (making a total of 6 months)

• Structural analysis (in principal components)

  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

  Until end of treatment (making a total of 6 months)

Study Arms (1)

Adults patients with chronic respiratory diseases

\- 200 adult patients with chronic respiratory diseases will be studied longitudinally and transversely (follow-up: 6 months) in 12 centres. 1. Sample 1 (n=110 patients) with COPD 2. Sample 2 (n=30 patients) with Diffuse interstitial lung diseases 3. Sample 3 (n=30 patients) with Pulmonary Arterial Hypertension primary or secondary (post embolic .....). 4. Sample 4 (n=30 patients) Adult with Cystic fibrosis

Other: Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.

Interventions

Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire. OTHER

Evaluation will be performed on a group of 200 patients deriving from 4 samples. * From these 200 patients, a sub-sample will be evaluated at 7 days (DYSLIM questionnaire only) for reproducibility (n = 50 patients: 10 patients with diffuse interstitial lung disease, 10 patients with cystic fibrosis, 10 patients with arterial pulmonary hypertension, 20 patients with COPD). * From these 200 patients, a sub-sample (COPD, n = 60) will be recruited among patients undergoing pulmonary rehabilitation at the beginning of the 6 months separating follow up visit and the initial assessment.

Also known as: Self-administered dyspnea questionnaire

Adults patients with chronic respiratory diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Population are adults patients with chronic respiratory diseases (Sample1: COPD; Sample 2: Diffuse interstitial lung diseases; Sample 3: Pulmonary Arterial Hypertension primary or secondary (post embolic .....); Sample 4: Adult with Cystic fibrosis)

You may qualify if:

• \) 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
• \) 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.
• \) Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post embolic .....).
• \) Sample4 (n = 30): Adult with Cystic fibrosis.
• \) patient with stable Status (no exacerbation for at least one month)

You may not qualify if:

• \) Patient under 18 years
• \) Inability to fill in questionnaires
• \) Other respiratory disease
• \) left symptomatic heart failure
• \) Obesity with a BMI\> 35 kg/m2
• \) Inability to perform PFT (Pulmonary Function Testing)
• \) Pregnant or breastfeeding woman
• \) Patient unable to consent
• \) Lack of social insurance coverage

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre

Paris, 75006, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Neoplasm Metastasis; Dyspnea; Pulmonary Arterial Hypertension; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Hypertension, Pulmonary; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Thierry Perez, MD

  CHRU de Lille / Hôpital Calmette - France

  STUDY CHAIR

• Nicolas ROCHE, MD, PhD

  APHP- Hopital Cochin

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: March 16, 2010
• Primary Completion: March 27, 2014
• Study Completion: December 30, 2015
• Last Updated: November 20, 2025

Record last verified: 2025-09

Locations

FR (1)