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

Plain Language Summary

Simplified for easier understanding

This study is validating a new questionnaire designed to measure how much patients with pulmonary arterial hypertension (PAH) understand about their condition. PAH is a serious disease involving high blood pressure in the arteries of the lungs. Good patient knowledge is linked to better self-management, and this questionnaire aims to assess that in a reliable way. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of Group 1 Pulmonary Arterial Hypertension (PAH) - You can read and understand the questionnaire language - You have provided informed consent - (For expert reviewers): You are a healthcare professional with recognized expertise in pulmonary hypertension **You may NOT be eligible if...** - You have cognitive, visual, or hearing impairments that would prevent you from completing the questionnaire - You have a different type of pulmonary hypertension (Groups 2–5) - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

São Paulo, São Paulo, Brazil

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NCT07120789

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