Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension

Condition(s) studied

Investigational drug(s) / intervention(s)

Application of Patient Knowledge Questionnaire on Pulmonary Hypertension: Participants will complete one version of the SAVOIR questionnaire, developed to assess patient knowledge about pulmonary arterial hypertension. Depending on the study phase, participants will contribute to content validation (expert judges), semantic validation (patients), or psychometric validation (patients). In the final phase, additional data including risk stratification (COMPERA 2.0) will be collected for correlational analysis.

Study 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

Primary outcome measure(s)

• Content Validity Index (CVI) of the Questionnaire Items — 4 weeks after expert panel review
  Proportion of agreement among expert judges regarding the relevance and clarity of each item. Items with CVI ≥ 0.80 will be considered valid.
• Semantic Clarity Rating by Patients — 2 weeks after patient interview
  Assessment of the clarity and comprehension of each item by patients using a structured form. Items with ≥ 85% of patients rating them as clear or very clear will be considered semantically valid.
• Internal Consistency of the Questionnaire (Cronbach's Alpha) — 4 weeks after questionnaire completion
  Psychometric evaluation of the final version of the SAVOIR questionnaire using Cronbach's alpha. A coefficient ≥ 0.70 will be considered acceptable. The analysis will be conducted in a sample of up to 200 patients.

Trial sites (1)

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