Validation of the Self-Assessment for Falls in the Elderly (SAFE) Questionnaire to Assess the Risk of Falls in People Aged 60 or Over.

This single-centre, cross-sectional diagnostic study will determine whether the new self-completed Self-Assessment for Falls in the Elderly (SAFE) questionnaire can classify fall-risk level (low, moderate, high) in adults ≥ 60 years as accurately as the current clinician-administered international algorithm that mixes yes/no questions with physical tests; to do so, about 300 participants will (1) sign consent, (2) answer the 5-minute SAFE, and (3) undergo guideline assessment and tests by a clinician in the same visit, after which researchers will compare SAFE and clinician results for sensitivity, specificity, and predictive values, examine agreement and correlations, and give immediate risk-based prevention advice: * Eligibility: men or women ≥ 60 y, stable walking/balance ≥ 1 month, able to read French and perform brief tests; legal guardianship or refusal excludes. * Participant tasks: complete SAFE; perform Timed Up-and-Go, 4 m gait speed, Five-Times-Sit-to-Stand and Short Physical Performance Battery (SPPB) under supervision * Benefits/Risks: instant personalised fall-risk feedback; SAFE is risk-free and physical tests carry only minimal supervised exertion. Falls are a leading cause of injury and death in older adults, and current assessments require trained staff; if SAFE proves equivalent, it could enable large-scale, low-cost self-screening and support future digital monitoring tools for fall prevention.

NCT Number	NCT06961812
Lead Sponsor	University Hospital, Montpellier
Conditions	Fall Prevention, Falls (Accidents) in Old Age
Enrollment	300 participants
Start Date	2025-05-02
Primary Completion	2026-05-02 (estimated)
Study Completion	2026-05-02 (estimated)
Updated on ClinicalTrials.gov	2025-05-08