An observational study in Pulmonary Arterial Hypertension (PAH), Quality of Life and Patients Reported Outcomes, sponsored by Chinese Pulmonary Vascular Disease Research Group. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Chinese Pulmonary Vascular Disease Research Group · Observational
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.
This is a multicenter, prospective observational study conducted in China to develop and validate a disease-specific quality of life scale for patients with pulmonary arterial hypertension (PAH).
The study consists of two main stages. The first stage involves item generation and selection based on literature review, expert consensus using the Delphi method, and patient interviews. The second stage includes multicenter validation to assess psychometric properties of the scale.
Participants will complete questionnaires at baseline, 1-2 weeks (for test-retest reliability), and 3 months (for responsiveness). Clinical data such as WHO functional class, 6-minute walk distance, and NT-proBNP will also be collected.
Psychometric evaluation includes internal consistency, construct validity, convergent and discriminant validity, and responsiveness. The study aims to establish a standardized, culturally adapted QoL assessment tool for Chinese PAH patients.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Chinese Pulmonary Vascular Disease Research Group is the lead sponsor of 16 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients diagnosed with pulmonary arterial hypertension receiving routine clinical care in tertiary hospitals in China.
Exclusion Criteria:
Patients diagnosed with pulmonary arterial hypertension participating in a prospective observational study and completing quality of life questionnaires.
Other: Questionnaire Assessment
Participants complete quality of life questionnaires and clinical data are collected. No therapeutic intervention is applied.
Psychometric properties of the PAH-QoL scale
Evaluation of the psychometric properties of the PAH-specific quality of life scale, including internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient), and construct validity assessed by factor analysis.
Time frame: Up to 3 months
Correlation with clinical parameters
Association between quality of life scores and clinical indicators, including WHO functional class and 6-minute walk distance.
Time frame: Up to 3 months
Responsiveness of the PAH-QoL scale
Ability of the scale to detect changes in patient condition over time.
Time frame: Baseline to 3 months
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. De-identified data may be available from the corresponding author upon reasonable request.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
Chinese Pulmonary Vascular Disease Research Group