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

NCT ID: NCT02229994

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-16
• Study Completion Date: 2015-12-30

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.

Detailed Description

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)

Like any psychometric instrument, an efficient evaluation of dyspnea scale should ideally satisfy all the following required features: evaluative, discriminant, good reproducibility, and high sensitivity to change.

The desired features apart from content validity are reproducibility and especially a high sensitivity to change, particularly following pulmonary rehabilitation.

Thus, this questionnaire should precisely enable to assess the benefit of rehabilitation and it's sustainment in maintenance phase.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Other Intervention Names

Self-administered dyspnea questionnaire

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris

UNKNOWN

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Perez, MD

Role: STUDY_CHAIR

CHRU de Lille / Hôpital Calmette - France

Nicolas ROCHE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP- Hopital Cochin

Locations

Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre

Paris, , France

Countries

France

Other Identifiers

2009-A00181-56

Identifier Type: -

Identifier Source: org_study_id