Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension
Recruiting · NCT07120789 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Sao Paulo General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo - São Paulo, São Paulo, Brazil