The PAH Disability and Bothersomeness Questionnaire

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03235401

Acronym

PAH-DBoQ

Enrollment

120

Registered

2017-08-01

Start date

2017-06-16

Completion date

2018-02-28

Last updated

2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension (PAH)

Keywords

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

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.

Interventions

OTHER37-items questionnaire

Patient will answer the PAH-DBoQ questionnaire

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactOlivier SITBON, PHD

olivier.sitbon@u-psud.fr145217972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026