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

Assistance Publique - Hôpitaux de Paris

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT02229994

2009-A00181-56

Details and patient eligibility

About

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.

Full 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.

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

199 participants in 1 patient group

Adults patients with chronic respiratory diseases

Description:

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

Treatment:

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