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The PAH Disability and Bothersomeness Questionnaire (PAH-DBoQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235401
Recruitment Status : Unknown
Verified July 2017 by Association de Recherche en Physiopathologie Respiratoire.
Recruitment status was:  Recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Collaborators:
GlaxoSmithKline
Soladis
Interlis
Information provided by (Responsible Party):
Association de Recherche en Physiopathologie Respiratoire

Brief Summary:
To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension (PAH) Other: 37-items questionnaire

Detailed Description:
A 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure (PROM) in PAH.The first two steps have been completed (qualitative study and Delphi consensus study) leading to the development of a provisional 37-items questionnaire. A reduction of items in this provisional questionnaire and the validation of the final questionnaire are the goals of the current study.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: "Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire"
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : December 16, 2017
Estimated Study Completion Date : February 2018


Group/Cohort Intervention/treatment
Pulmonary Arterial Hypertension patients Other: 37-items questionnaire
Patient will answer the PAH-DBoQ questionnaire




Primary Outcome Measures :
  1. Cronbach's alpha≥ 0.7 [ Time Frame: at the end of the study (an average of 6 months) ]
    Internal consistency of the PAH Disability and Bothersomeness Questionnaire will be assessed with Cronhbach's alpha


Secondary Outcome Measures :
  1. Low rate of answers (≤95%) [ Time Frame: at the end of the study (an average of 6 months) ]
    low rate of answers will help reducing the number of questionnaire's items



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  • 120 patients with idiopathic and heritable PAH (40 of which will be selected for a test-retest procedure)
  • Patients with PAH associated with other diseases will be excluded in order to clearly circumscribe the results to PAH
Criteria

Inclusion Criteria:

  • patients with idiopathic and heritable PAH;
  • patients over 18;
  • male and female;
  • NYHA Functional Class I, II, III & IV;
  • Written consent signed
  • Patients with a good understanding of the French - language
  • Patient affiliated with a social security scheme

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients with other pathologies associated with PAH (Group 1)
  • Patients with other forms of pulmonary hypertension (groups 2, 3, 4 and 5)
  • Non-consenting patients
  • Patients who do not have a good understanding of the French language

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): NCT03235401


Contacts
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Contact: Olivier SITBON, PHD 145217972 ext +33 olivier.sitbon@u-psud.fr

Locations
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France
Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Recruiting
Le Kremlin-Bicêtre, Val De Marne, France, 94270
Contact: Olivier SITBON, PHD    +33-(0)1 45 21 79 72    olivier.sitbon@u-psud.fr   
Contact: Sophie ALAMI, PHD    00 33 68 50 64 857    interlis.france@gmail.com   
Sponsors and Collaborators
Association de Recherche en Physiopathologie Respiratoire
GlaxoSmithKline
Soladis
Interlis
Investigators
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Principal Investigator: Olivier SITBON, PHD Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France

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Responsible Party: Association de Recherche en Physiopathologie Respiratoire
ClinicalTrials.gov Identifier: NCT03235401    
Other Study ID Numbers: PAH-DBoQ
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association de Recherche en Physiopathologie Respiratoire:
Questionnaire
Disability assessment
Bothersomeness
Pulmonary Arterial Hypertension
patient-reported outcome measure
New York Heart Association (NYHA) functional class
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases