Development and Validation of a Chinese Quality of Life Scale for Pulmonary Arterial Hypertension

Conditions: Pulmonary Arterial Hypertension (PAH), Quality of Life, Patients Reported Outcomes

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 300

Sponsor: Chinese Pulmonary Vascular Disease Research Group

Summary

This study aims to develop and validate a culturally appropriate, reliable, and clinically applicable patient-reported outcome (PRO) instrument to assess quality of life in patients with pulmonary arterial hypertension (PAH) in China. The study includes two phases: (1) scale development using literature review, Delphi expert consultation, and patient interviews; and (2) multicenter prospective observational validation to evaluate reliability, validity, and responsiveness. The final scale is expected to support clinical assessment, treatment monitoring, and health policy decision-making.

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years * Diagnosed with pulmonary arterial hypertension * Able to read and complete questionnaires * Provided informed consent Exclusion Criteria: * Severe physical condition preventing participation * History of psychiatric disorders or current use of psychiatric medication * Pregnancy or lactation * Any condition preventing completion of questionnaires

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07570615). StuddyBuddy aggregates publicly available trial information.