The PAH Disability and Bothersomeness Questionnaire (PAH-DBoQ)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Arterial Hypertension (PAH)
• Intervention / Treatment: Other: 37-items questionnaire

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Olivier SITBON, PHD; Phone Number: +33 145217972; Email: olivier.sitbon@u-psud.fr

Study Locations

• France
  • Val De Marne
    • Le Kremlin-Bicêtre, Val De Marne, France, 94270
      • Recruiting
      • Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,
      • Contact: Olivier SITBON, PHD; Phone Number: +33-(0)1 45 21 79 72; Email: olivier.sitbon@u-psud.fr
      • Contact: Sophie ALAMI, PHD; Phone Number: 00 33 68 50 64 857; Email: interlis.france@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary Arterial Hypertension patients	Other: 37-items questionnaire; Patient will answer the PAH-DBoQ questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Association de Recherche en Physiopathologie Respiratoire
• Collaborators: GlaxoSmithKline; Soladis; Interlis
• Investigators: Principal Investigator: Olivier SITBON, PHD, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Anticipated): December 16, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Questionnaire; Pulmonary Arterial Hypertension; Disability assessment; Bothersomeness; patient-reported outcome measure; New York Heart Association (NYHA) functional class
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: PAH-DBoQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No