The PAH Disability and Bothersomeness Questionnaire

Pulmonary Arterial Hypertension (PAH) Clinical Trial

— PAH-DBoQ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235401
• Other study ID #: PAH-DBoQ
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2017
• Last updated: July 28, 2017
• Start date: June 16, 2017
• Est. completion date: February 2018

Study information

• Verified date: July 2017
• Source: Association de Recherche en Physiopathologie Respiratoire
• Contact: Olivier SITBON, PHD
• Phone: 145217972
• Email: olivier.sitbon[@]u-psud.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2018
• Est. primary completion date: December 16, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension (PAH)

Intervention

Other:
• 37-items questionnaire
Patient will answer the PAH-DBoQ questionnaire

Locations

Country	Name	City	State
France	Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,	Le Kremlin-Bicêtre	Val De Marne

Sponsors (4)

Lead Sponsor	Collaborator
Association de Recherche en Physiopathologie Respiratoire	GlaxoSmithKline, Interlis, Soladis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cronbach's alpha= 0.7	Internal consistency of the PAH Disability and Bothersomeness Questionnaire will be assessed with Cronhbach's alpha	at the end of the study (an average of 6 months)
Secondary	Low rate of answers (=95%)	low rate of answers will help reducing the number of questionnaire's items	at the end of the study (an average of 6 months)