Clinical trial NCT02229994: Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases
Official title: Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris
First posted: 2014-09-03
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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

Primary outcomes:
measure: Psychometric validity of the questionnaire
timeFrame: Until end of treatment (making a total of 6 months)
Secondary outcomes:
measure: Analysis of responses distribution
timeFrame: Until end of treatment (making a total of 6 months)
measure: Structural analysis (in principal components)
timeFrame: Until end of treatment (making a total of 6 months)
measure: External and convergent validity
timeFrame: Until end of treatment (making a total of 6 months)
measure: Internal coherence
timeFrame: Until end of treatment (making a total of 6 months)
measure: Reproducibility
timeFrame: Until end of treatment (making a total of 6 months)
measure: Reproducibility
timeFrame: 7 days
measure: Discriminating properties
timeFrame: Until end of treatment (making a total of 6 months)
measure: Derivation of a scoring algorithm
timeFrame: Until end of treatment (making a total of 6 months)
measure: Sensitivity to change
timeFrame: Until end of treatment (making a total of 6 months)
measure: Minimal difference clinically relevant
timeFrame: Until end of treatment (making a total of 6 months)
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre
Study officials:
affiliation: CHRU de Lille / Hôpital Calmette - France
name: Thierry Perez, MD
role: STUDY_CHAIR
affiliation: APHP- Hopital Cochin
name: Nicolas ROCHE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: