MedTrace Logo

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

NCT06961812 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-05-08

No results posted yet for this study

Summary

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.

Conditions

  • Fall Prevention
  • Falls (Accidents) in Old Age

Interventions

DIAGNOSTIC_TEST

Questionnaire and Physical Exam

Next, the risk of falling will be assessed by a healthcare professional using a hetero-questionnaire and physical tests, as proposed in the algorithm for global recommendations (routine care). These tests include a detailed characterisation of the history of falls, the Timed Up and Go, the Five Times Sit to Stand, the 4 m walking speed and the Short Physical Performance Battery.

DIAGNOSTIC_TEST

Safe Self-Administered Questionnaire

All people who agree to take part in the study will first complete the SAFE self-questionnaire (intervention). the Self Assessment for Falls in the Elderly (SAFE), an auto-questionnaire that converts the binary items and performance tests of the 2022 World Guidelines for Falls Prevention and Management into visual analogue scales (100 mm each).

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Jean Baptiste ROBIAUD, MD · University Hospital, Montpellier

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2026-05-02
Completion
2026-05-02

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06961812 on ClinicalTrials.gov