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NCT Number: NCT07570615

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Assessment

Other

Participants complete quality of life questionnaires and clinical data are collected. No therapeutic intervention is applied.

Primary outcomes

  1. Psychometric properties of the PAH-QoL scale

    Time frame: Up to 3 months

    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.

Secondary outcomes

  1. Correlation with clinical parameters

    Time frame: Up to 3 months

    Association between quality of life scores and clinical indicators, including WHO functional class and 6-minute walk distance.

  2. Responsiveness of the PAH-QoL scale

    Time frame: Baseline to 3 months

    Ability of the scale to detect changes in patient condition over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Chinese Pulmonary Vascular Disease Research Group

Other

Registry information

Official study title

Development and Validation of a Chinese Patient-Reported Outcome Measure for Quality of Life in Pulmonary Arterial Hypertension Patients

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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