Keywords
Stroke
Cross-Sectional Study
Protocol
Validation
European Country
How to Cite
Abstract
Objectives. The EDUSTROKE project aims to (1) assess stroke-related health literacy (HL) in the general populations of Albania and Italy and identify sociodemographic and behavioral determinants of low HL, and (2) linguistically and psychometrically validate stroke-related HL questionnaires for cross-cultural use in both countries.
Trial Design. This is a cross-sectional, two-phase, multicentre observational study. Phase 1 consists of a population-based survey to estimate levels and determinants of stroke-related HL. Phase 2 focuses on the linguistic, cultural, and psychometric validation of the instruments, following COSMIN and SPIRIT recommendations for measurement studies.
Participants and Settings. Approximately 1,000 adults (≥18 years) will be recruited in each country using a stratified convenience sampling approach with quota targets for age, sex, geographic region, and urban–rural residence. Participants will be recruited in public settings and through an online survey. Healthcare professionals and individuals unable to provide informed consent will be excluded.
Interventions. This is an observational study with no clinical intervention. Participants will complete a structured questionnaire including a sociodemographic survey, the Stroke Knowledge Test, the Awareness of Stroke Symptoms and Risk Factors Questionnaire, and the Stroke Risk Factor Knowledge and Perception Questionnaire. Questionnaires will undergo forward–backward translation, cognitive pretesting, and expert content validation.
Primary and Secondary Outcomes. The primary outcome is a latent stroke-related HL score derived from confirmatory factor analysis of combined questionnaire items. Secondary outcomes include identification of HL predictors through weighted multivariable regression models and evaluation of psychometric properties (content validity, reliability, factor structure, and measurement invariance across countries).
Conclusions. EDUSTROKE will provide population-level evidence on stroke-related HL in two European countries with differing healthcare contexts and deliver validated tools for cross-national HL assessment, supporting future public health education and prevention strategies.
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