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The PAH Disability and Bothersomeness Questionnaire (PAH-DBoQ)

A

Association de Recherche en Physiopathologie Respiratoire

Status

Unknown

Conditions

Pulmonary Arterial Hypertension (PAH)

Treatments

Other: 37-items questionnaire

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03235401
PAH-DBoQ

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Pulmonary Arterial Hypertension patients
Treatment:
Other: 37-items questionnaire

Trial contacts and locations

1

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Central trial contact

Olivier SITBON, PHD

Data sourced from clinicaltrials.gov

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