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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

Qualifiers

People aged 60 or over, judged by the investigator to be in stable clinical condition as regards walking and balance for at least one month,

Able to perform the necessary physical assessments

Disqualifiers

Unable, according to the investigator, to answer a self-questionnaire,

Patient's refusal to take part in the study

Absence of a caregiver if the participant is unable to answer the questionnaire alone

Unable to understand the information note

Trial design

Treatments tested in this trial

  • Questionnaire and Physical Exam
  • Safe Self-Administered Questionnaire

Treatment groups

300 Participants
are divided into 1 treatment group