Hypertension Clinical Trials

Find Hypertension Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Caio Fernandes Principal Investigato, PhD
caio.cesar@hc.fm.usp.br
+55 11 2661 5034
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 215
Treatments
Experimental: Single Group
Participants in this arm will take part in one of three phases of the questionnaire validation study:~1. content validation by expert judges,~2. semantic validation by patients with pulmonary arterial hypertension (PAH),~3. psychometric validation in a larger sample of up to 200 patients with confirmed PAH.~In the psychometric phase, participants will complete the final version of the SAVOIR questionnaire. Additional clinical and functional data will be collected from medical records, including:~risk stratification using the COMPERA 2.0 method,~These data will be used to explore associations between patient knowledge and clinical/functional outcomes.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital

This content was sourced from clinicaltrials.gov