Testing a patient questionnaire about pulmonary hypertension knowledge
Content, Semantic, and Psychometric Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension
This project will test a questionnaire to measure what adults with pulmonary arterial hypertension know about their condition, treatments, and self-care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 215 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07120789 on ClinicalTrials.gov |
What this trial studies
The project will develop and validate a Patient Knowledge Questionnaire for pulmonary arterial hypertension using four sequential phases: item generation from guidelines and literature, content validation by expert judges, semantic testing with patients, and psychometric testing in up to 200 confirmed PAH patients. Items will cover basic concepts, signs and symptoms, diagnosis and tests, treatments and mechanisms, adherence and self-care, and side-effect management, and will include a multiple-choice format with an 'I don't know' option. Content validity will be quantified using item- and scale-level Content Validity Index (I-CVI and S-CVI) and items below threshold will be revised or removed. Clinical and functional data including COMPERA 2.0 risk stratification will be collected from medical records to describe the sample and support instrument validation, and the work will be conducted at a reference outpatient center in São Paulo, Brazil.
Who should consider this trial
Good fit: Adults aged 18 or older with a confirmed diagnosis of Group 1 pulmonary arterial hypertension who can read the questionnaire language and provide informed consent are ideal candidates.
Not a fit: Patients with cognitive, visual, or hearing impairments that prevent understanding the questionnaire, those who are clinically unstable, or those with non-Group 1 pulmonary hypertension are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the questionnaire could help clinicians identify knowledge gaps and guide targeted education to improve self-care, adherence, and clinical management for people with PAH.
How similar studies have performed: Questionnaire development and validation methods have been successfully used in other chronic diseases, but a dedicated, validated PAH patient knowledge instrument is relatively novel with limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
São Paulo, São Paulo
- Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Caio Fernandes Principal Investigato, PhD
- Email: caio.cesar@hc.fm.usp.br
- Phone: +55 11 2661 5034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.