The PAH Disability and Bothersomeness Questionnaire

• Conditions: Pulmonary Arterial Hypertension (PAH)

• Registration Number: NCT03235401
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2017-06-16
• Status Verified: 2017-07
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Last Update Submitted: 2017-07-28
• Study First Posted: 2017-08-01
• Last Update Posted: 2017-08-01
• Primary Completion: 2017-12-16
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cronbach's alpha≥ 0.7	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

Name	Time	Method
Low rate of answers (≤95%)	at the end of the study (an average of 6 months)	low rate of answers will help reducing the number of questionnaire's items

Trial Locations

Locations (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