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

COPD (With - Without Rehabilitation) Clinical Trial

— DYSLIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229994
• Other study ID #: 2009-A00181-56
• Status: Completed
• Phase: N/A
• First received: August 29, 2014
• Last updated: July 31, 2017
• Start date: March 16, 2010
• Est. completion date: December 30, 2015

Study information

• Verified date: July 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: December 30, 2015
• Est. primary completion date: March 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD (With - Without Rehabilitation)
• Cystic Fibrosis
• Cystic Fibrosis of the Adult
• Diffuse Interstitial Lung Diseases
• Dyspnea
• Familial Primary Pulmonary Hypertension
• Fibrosis
• Hypertension
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....)
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris

Country where clinical trial is conducted

France, 

Outcome

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