The PAH Disability and Bothersomeness Questionnaire

NCT03235401 | Unknown

• 1 other identifier: PAH-DBoQ
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension (PAH)

Keywords

Questionnaire; Disability assessment; Bothersomeness; Pulmonary Arterial Hypertension; patient-reported outcome measure; New York Heart Association (NYHA) functional class

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Low rate of answers (≤95%)

  at the end of the study (an average of 6 months)

Study Arms (1)

Pulmonary Arterial Hypertension patients

Other: 37-items questionnaire

Interventions

37-items questionnaire OTHER

Patient will answer the PAH-DBoQ questionnaire

Pulmonary Arterial Hypertension patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 120 patients with idiopathic and heritable PAH (40 of which will be selected for a test-retest procedure) * Patients with PAH associated with other diseases will be excluded in order to clearly circumscribe the results to PAH

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association de Recherche en Physiopathologie Respiratoire: lead
• GlaxoSmithKline: collaborator
• Soladis: collaborator
• Interlis: collaborator

Study Sites (1)

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

Le Kremlin-Bicêtre, Val De Marne, 94270, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Olivier SITBON, PHD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier SITBON, PHD

CONTACT

145217972; olivier.sitbon@u-psud.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: June 16, 2017
• Primary Completion: December 16, 2017
• Study Completion: February 1, 2018
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)