Status:
UNKNOWN
The PAH Disability and Bothersomeness Questionnaire
Lead Sponsor:
Association de Recherche en Physiopathologie Respiratoire
Collaborating Sponsors:
GlaxoSmithKline
Soladis
Conditions:
Pulmonary Arterial Hypertension (PAH)
Eligibility:
All Genders
18+ years
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.
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) leadin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03235401
Start Date
June 16 2017
End Date
February 1 2018
Last Update
August 1 2017
Active Locations (1)
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1
Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,
Le Kremlin-Bicêtre, Val De Marne, France, 94270