Testing a patient questionnaire about pulmonary hypertension knowledge

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Improving adherence to PAH treatment with telemedicine and patient guidance

  This study will try whether regular telemedicine check-ins and guided education help people with PAH stick to their oral medications and manage side effects.

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• Levosimendan to see if it helps the heart after PEA in CTEPH

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• Sleep problems in PAH patients: how sleep breathing relates to PAH outcomes

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  Recruiting Chinese Pulmonary Vascular Disease Research Group · Beijing · NCT07852403

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.