The PAH Disability and Bothersomeness Questionnaire | NCT03235401

Studies
The PAH Disability and Bothersomeness Questionnaire

NCT03235401

Sponsor

Association de Recherche en Physiopathologie Respiratoire

Status

Unknown status

Last Update Posted

Aug 1, 2017Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Pulmonary Arterial Hypertension (PAH)

Interventions

37-items questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2017Actual

Primary Completion Date

Dec 16, 2017Estimated

Completion Date

Feb 2018Estimated

First Submitted Date

Jul 28, 2017

First Submission Date that Met QC Criteria

Jul 28, 2017

First Posted Date

Aug 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2017

Last Update Posted Date

Aug 1, 2017Actual

Name	Class
GlaxoSmithKline	INDUSTRY
Soladis	INDUSTRY
Interlis	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary Arterial Hypertension patients			Other: 37-items questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
37-items questionnaire	Other	Patient will answer the PAH-DBoQ questionnaire	Pulmonary Arterial Hypertension patients

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olivier SITBON, PHD	Contact	145217972	+33	olivier.sitbon@u-psud.fr

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,	Recruiting	Le Kremlin-Bicêtre	Val De Marne	94270	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided