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

Completed

• Conditions: Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....); Cystic Fibrosis of the Adult; COPD (With - Without Rehabilitation); Diffuse Interstitial Lung Diseases
• Interventions: Other: Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.

• Registration Number: NCT02229994
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-03-16
• Primary Completion: 2014-03-27
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Study Completion: 2015-12-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults patients with chronic respiratory diseases	Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.	- 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

Primary Outcome Measures

Name	Time	Method
Psychometric validity of the questionnaire	Until end of treatment (making a total of 6 months)	Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire

Secondary Outcome Measures

Name	Time	Method
Structural analysis (in principal components)	Until end of treatment (making a total of 6 months)	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Analysis of responses distribution	Until end of treatment (making a total of 6 months)	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Reproducibility	7 days	for a sub sample of 50 patients, Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
External and convergent validity	Until end of treatment (making a total of 6 months)	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Internal coherence	Until end of treatment (making a total of 6 months)	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Discriminating properties	Until end of treatment (making a total of 6 months)	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Derivation of a scoring algorithm	Until end of treatment (making a total of 6 months)	Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Sensitivity to change	Until end of treatment (making a total of 6 months)	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.
Minimal difference clinically relevant	Until end of treatment (making a total of 6 months)	Cross-sectional data necessary to assess the psychometric validity of a self-administered dyspnea questionnaire

Trial Locations

Locations (1)

Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre; 🇫🇷 Paris, France