RecruitingNot ApplicableNCT07120789

Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension

Content, Semantic, and Psychometric Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension

Sponsor

University of Sao Paulo General Hospital

Enrollment

215 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension Pulmonary Arterial Hypertension PAH Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Summary

This methodological study aims to develop and validate a questionnaire named for the Assessment of Patient Knowledge in Pulmonary Arterial Hypertension. The study will be conducted in four phases: (1) questionnaire development based on guidelines and literature; (2) content validation by expert judges; (3) semantic validation with patients; and (4) psychometric testing in a sample of up to 200 patients with confirmed pulmonary arterial hypertension (PAH). In addition to validation, the study will collect clinical and functional data from medical records, including risk stratification using the COMPERA 2.0 method The final instrument is expected to support patient education strategies and contribute to improved clinical management of PAH.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Adults aged 18 years or older
Confirmed diagnosis of Group 1 Pulmonary Arterial Hypertension (PAH)
Ability to read and understand the questionnaire language
Provided informed consent to participate in the study
For expert judges (content validation phase): professionals with recognized expertise in pulmonary hypertension, with academic or clinical experience in the field

Exclusion Criteria3

Cognitive, visual, or auditory impairments that hinder questionnaire comprehension
Refusal to participate or withdrawal of informed consent
Inability to complete the questionnaire due to clinical instability

Interventions

OTHERApplication of Patient Knowledge Questionnaire on Pulmonary Hypertension

Participants will complete one version of the SAVOIR questionnaire, developed to assess patient knowledge about pulmonary arterial hypertension. Depending on the study phase, participants will contribute to content validation (expert judges), semantic validation (patients), or psychometric validation (patients). In the final phase, additional data including risk stratification (COMPERA 2.0) will be collected for correlational analysis.