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

NCT07570615 | Not Yet Recruiting

• 1 other identifier: China PAH-QoL Study
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Arterial Hypertension (PAH); Quality of Life; Patients Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 months

Secondary Outcomes (2)

• Correlation with clinical parameters

  Up to 3 months

• Responsiveness of the PAH-QoL scale

  Baseline to 3 months

Study Arms (1)

PAH Patients

Patients diagnosed with pulmonary arterial hypertension participating in a prospective observational study and completing quality of life questionnaires.

Other: Questionnaire Assessment

Interventions

Questionnaire Assessment OTHER

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

PAH Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with pulmonary arterial hypertension receiving routine clinical care in tertiary hospitals in China.

You may qualify if:

• Age ≥18 years
• Diagnosed with pulmonary arterial hypertension
• Able to read and complete questionnaires
• Provided informed consent

You may not qualify if:

• Severe physical condition preventing participation
• History of psychiatric disorders or current use of psychiatric medication
• Pregnancy or lactation
• Any condition preventing completion of questionnaires

Sponsors & Collaborators

• Chinese Pulmonary Vascular Disease Research Group: lead

Related Publications (3)

• Yarlas A, Mathai SC, Nathan SD, DuBrock HM, Morland K, Anderson N, Kosinski M, Lin X, Classi P. Considerations When Selecting Patient-Reported Outcome Measures for Assessment of Health-Related Quality of Life in Patients With Pulmonary Hypertension: A Narrative Review. Chest. 2022 Nov;162(5):1163-1175. doi: 10.1016/j.chest.2022.08.2206. Epub 2022 Aug 23.

  PMID: 35998707 BACKGROUND

• McCollister D, Shaffer S, Badesch DB, Filusch A, Hunsche E, Schuler R, Wiklund I, Peacock A; IRB information for the 5 clinical sites. Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT(R)) questionnaire: a new patient-reported outcome instrument for PAH. Respir Res. 2016 Jun 14;17(1):72. doi: 10.1186/s12931-016-0388-6.

  PMID: 27301413 BACKGROUND

• Rose SW, Highland KB, Kelkar AA. Clinical Utility of Patient-Reported Outcome Instruments in the Management of Pulmonary Hypertension: A Systematic Review. JACC Heart Fail. 2024 Feb;12(2):366-376. doi: 10.1016/j.jchf.2023.09.008. Epub 2023 Oct 25.

  PMID: 37897461 BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Qin Luo

CONTACT

13581777615; luoqin2009@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share