The PAH Disability and Bothersomeness Questionnaire

NCT ID: NCT03235401

Last Updated: 2017-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-16

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Pulmonary Arterial Hypertension (PAH)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pulmonary Arterial Hypertension patients

37-items questionnaire

Intervention Type OTHER

Patient will answer the PAH-DBoQ questionnaire

Interventions

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37-items questionnaire

Patient will answer the PAH-DBoQ questionnaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Soladis

INDUSTRY

Sponsor Role collaborator

Interlis

UNKNOWN

Sponsor Role collaborator

Association de Recherche en Physiopathologie Respiratoire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier SITBON, PHD

Role: PRINCIPAL_INVESTIGATOR

Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France

Locations

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Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,

Le Kremlin-Bicêtre, Val De Marne, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier SITBON, PHD

Role: CONTACT

145217972 ext. +33

Facility Contacts

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Olivier SITBON, PHD

Role: primary

+33-(0)1 45 21 79 72

Sophie ALAMI, PHD

Role: backup

00 33 68 50 64 857

Other Identifiers

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PAH-DBoQ

Identifier Type: -

Identifier Source: org_study_id

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