"Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire"

The PAH Disability and Bothersomeness Questionnaire

Sponsors

Lead sponsor: Association de Recherche en Physiopathologie Respiratoire

Collaborator: GlaxoSmithKline
Soladis
Interlis

Source 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.

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.

Overall Status Unknown status
Start Date June 16, 2017
Completion Date February 2018
Primary Completion Date December 16, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Cronbach's alpha≥ 0.7 at the end of the study (an average of 6 months)
Secondary Outcome
Measure Time Frame
Low rate of answers (≤95%) at the end of the study (an average of 6 months)
Enrollment 120
Condition
Intervention

Intervention type: Other

Intervention name: 37-items questionnaire

Description: Patient will answer the PAH-DBoQ questionnaire

Arm group label: Pulmonary Arterial Hypertension patients

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Overall Official
Last Name Role Affiliation
Olivier SITBON, PHD Principal Investigator Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France
Overall Contact

Last name: Olivier SITBON, PHD

Phone: 145217972

Phone ext: +33

Email: [email protected]

Location
facility status contact contact_backup
Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Recruiting Olivier SITBON, PHD +33-(0)1 45 21 79 72 [email protected]
Location Countries

France

Verification Date

July 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Pulmonary Arterial Hypertension patients

Acronym PAH-DBoQ
Patient Data No
Study Design Info

Observational model: Case-Only

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov