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

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ClinicalTrials.gov Identifier: NCT02229994
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris
Information provided by (Responsible Party):
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.

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

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.


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Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases
Actual Study Start Date : March 16, 2010
Actual Primary Completion Date : March 27, 2014
Actual Study Completion Date : December 30, 2015


Group/Cohort Intervention/treatment
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
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.
Other Name: Self-administered dyspnea questionnaire




Primary Outcome Measures :
  1. Psychometric validity of the questionnaire [ Time Frame: 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 :
  1. Analysis of responses distribution [ Time Frame: 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

  2. Structural analysis (in principal components) [ Time Frame: 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

  3. External and convergent validity [ Time Frame: 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

  4. Internal coherence [ Time Frame: 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

  5. Reproducibility [ Time Frame: 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

  6. Reproducibility [ Time Frame: 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

  7. Discriminating properties [ Time Frame: 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

  8. Derivation of a scoring algorithm [ Time Frame: 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

  9. Sensitivity to change [ Time Frame: 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.


  10. Minimal difference clinically relevant [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229994


Locations
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France
Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre
Paris, France, 75006
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris
Investigators
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Study Chair: Thierry Perez, MD CHRU de Lille / Hôpital Calmette - France
Principal Investigator: Nicolas ROCHE, MD, PhD APHP- Hopital Cochin

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02229994     History of Changes
Other Study ID Numbers: 2009-A00181-56
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Dyspnea
Self-administered questionnaire
Chronic respiratory disease
COPD
Diffuse interstitial lung diseases
Pulmonary arterial hypertension
Cystic fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Lung Diseases
Dyspnea
Lung Diseases, Interstitial
Respiration Disorders
Hypertension
Fibrosis
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms