NCT07120789Recruiting
Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension
Content, Semantic, and Psychometric Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 215 (estimated)
- First submitted
- 4 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Sao Paulo General Hospital
- NCT number
- NCT07120789
What you commit to
- Study type: Interventional
- Planned participants: 215
- From 1 Sept 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
Related publications
- The SAVOIR study: protocol for the development and validation of a PAH knowledge questionnaire.Respir Med · 2026 · PMID 42425312
This page is information, not medical advice. Discuss any trial with your doctor.