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 | Not Yet Recruiting

• 1 other identifier: REHCMPL25_0035
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Falls; Functional Assessment; Predictive Value of Tests; Aging; Fallers Aged 60 Years and Older

Outcome Measures

Primary Outcomes (6)

• Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). sensitivity

  Based on predefined VAS thresholds in the self-questionnaire, we apply the global recommendations algorithm to classify patients into low, moderate, and high risk of falling: High Risk: At least one of the following: Two or more falls in the last year. One fall with injury in the last year. One fall with inability to get up in the last year. Unexplained fall in the last year. Frailty: At least three of the five Fried factors (fatigue, \>5 seconds for 4 meters, \>15 seconds for 5 chair lifts, \>4.5 kg weight loss in one year, sedentary lifestyle). Moderate Risk: Non-severe fall, fear of falling, or instability while walking/standing, associated with: TUG ≥ 15 seconds, or ≥ 5 seconds to walk 4 meters. Low Risk: One non-severe fall, fear of falling, or instability, but no frailty and normal TUG (Timed Up and Go) and walking speed. We compare the statistical performance of SAFE with the reference standard using contingency tables, reporting sensitivity

  At inclusion

• Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). specificity

  Based on predefined VAS thresholds in the self-questionnaire, we apply the global recommendations algorithm to classify patients into low, moderate, and high risk of falling: High Risk: At least one of the following: Two or more falls in the last year. One fall with injury in the last year. One fall with inability to get up in the last year. Unexplained fall in the last year. Frailty: At least three of the five Fried factors (fatigue, \>5 seconds for 4 meters, \>15 seconds for 5 chair lifts, \>4.5 kg weight loss in one year, sedentary lifestyle). Moderate Risk: Non-severe fall, fear of falling, or instability while walking/standing, associated with: TUG ≥ 15 seconds, or ≥ 5 seconds to walk 4 meters. Low Risk: One non-severe fall, fear of falling, or instability, but no frailty and normal TUG and walking speed. We compare the statistical performance of SAFE with the reference standard using contingency tables, reporting specificity

  At inclusion

• Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). positive predictive values

  Based on predefined VAS thresholds in the self-questionnaire, we apply the global recommendations algorithm to classify patients into low, moderate, and high risk of falling: High Risk: At least one of the following: Two or more falls in the last year. One fall with injury in the last year. One fall with inability to get up in the last year. Unexplained fall in the last year. Frailty: At least three of the five Fried factors (fatigue, \>5 seconds for 4 meters, \>15 seconds for 5 chair lifts, \>4.5 kg weight loss in one year, sedentary lifestyle). Moderate Risk: Non-severe fall, fear of falling, or instability while walking/standing, associated with: TUG ≥ 15 seconds, or ≥ 5 seconds to walk 4 meters. Low Risk: One non-severe fall, fear of falling, or instability, but no frailty and normal TUG and walking speed. We compare the statistical performance of SAFE with the reference standard using contingency tables, reporting positive predictive values,

  At inclusion

• Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). negative predictive values

  Based on predefined VAS thresholds in the self-questionnaire, we apply the global recommendations algorithm to classify patients into low, moderate, and high risk of falling: High Risk: At least one of the following: Two or more falls in the last year. One fall with injury in the last year. One fall with inability to get up in the last year. Unexplained fall in the last year. Frailty: At least three of the five Fried factors (fatigue, \>5 seconds for 4 meters, \>15 seconds for 5 chair lifts, \>4.5 kg weight loss in one year, sedentary lifestyle). Moderate Risk: Non-severe fall, fear of falling, or instability while walking/standing, associated with: TUG ≥ 15 seconds, or ≥ 5 seconds to walk 4 meters. Low Risk: One non-severe fall, fear of falling, or instability, but no frailty and normal TUG and walking speed. We compare the statistical performance of SAFE with the reference standard using contingency tables, reporting negative predictive values

  At inclusion

• Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). likelihood ratios

  Based on predefined VAS thresholds in the self-questionnaire, we apply the global recommendations algorithm to classify patients into low, moderate, and high risk of falling: High Risk: At least one of the following: Two or more falls in the last year. One fall with injury in the last year. One fall with inability to get up in the last year. Unexplained fall in the last year. Frailty: At least three of the five Fried factors (fatigue, \>5 seconds for 4 meters, \>15 seconds for 5 chair lifts, \>4.5 kg weight loss in one year, sedentary lifestyle). Moderate Risk: Non-severe fall, fear of falling, or instability while walking/standing, associated with: TUG ≥ 15 seconds, or ≥ 5 seconds to walk 4 meters. Low Risk: One non-severe fall, fear of falling, or instability, but no frailty and normal TUG and walking speed. We compare the statistical performance of SAFE with the reference standard using contingency tables, reporting likelihood ratios

  At inclusion

• Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). diagnostic odds ratio

  Based on predefined VAS thresholds in the self-questionnaire, we apply the global recommendations algorithm to classify patients into low, moderate, and high risk of falling: High Risk: At least one of the following: Two or more falls in the last year. One fall with injury in the last year. One fall with inability to get up in the last year. Unexplained fall in the last year. Frailty: At least three of the five Fried factors (fatigue, \>5 seconds for 4 meters, \>15 seconds for 5 chair lifts, \>4.5 kg weight loss in one year, sedentary lifestyle). Moderate Risk: Non-severe fall, fear of falling, or instability while walking/standing, associated with: TUG ≥ 15 seconds, or ≥ 5 seconds to walk 4 meters. Low Risk: One non-severe fall, fear of falling, or instability, but no frailty and normal TUG and walking speed. We compare the statistical performance of SAFE with the reference standard using contingency tables, reporting diagnostic odds ratio

  At inclusion

Secondary Outcomes (4)

• VAS thresholds for the self-questionnaire

  At inclusion

• Concordance analyses

  At inclusion

• Point-biserial correlations

  At inclusion

• Pearson correlation analysis

  At inclusion

Study Arms (1)

Fall Risk Assessment

EXPERIMENTAL

Patients or carers over 60 consulting the geriatrics department at Montpellier University Hospital

Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: Safe Self-Administered Questionnaire

Interventions

Questionnaire and Physical Exam DIAGNOSTIC_TEST

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.

Fall Risk Assessment

Safe Self-Administered Questionnaire DIAGNOSTIC_TEST

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).

Fall Risk Assessment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Opposition of the proxy or legal guardian if the participant is under legal protection (guardianship, curatorship, safeguard of justice)
• Subject deprived of liberty (art. L. 1121-6) (by judicial or administrative decision, or forced hospitalization)
• Not affiliated to a French social security scheme or beneficiary of such a scheme (L1121-8-1)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, Hérault, 34090, France

Location

Related Publications (9)

• Montero-Odasso M, van der Velde N, Martin FC, Petrovic M, Tan MP, Ryg J, Aguilar-Navarro S, Alexander NB, Becker C, Blain H, Bourke R, Cameron ID, Camicioli R, Clemson L, Close J, Delbaere K, Duan L, Duque G, Dyer SM, Freiberger E, Ganz DA, Gomez F, Hausdorff JM, Hogan DB, Hunter SMW, Jauregui JR, Kamkar N, Kenny RA, Lamb SE, Latham NK, Lipsitz LA, Liu-Ambrose T, Logan P, Lord SR, Mallet L, Marsh D, Milisen K, Moctezuma-Gallegos R, Morris ME, Nieuwboer A, Perracini MR, Pieruccini-Faria F, Pighills A, Said C, Sejdic E, Sherrington C, Skelton DA, Dsouza S, Speechley M, Stark S, Todd C, Troen BR, van der Cammen T, Verghese J, Vlaeyen E, Watt JA, Masud T; Task Force on Global Guidelines for Falls in Older Adults. World guidelines for falls prevention and management for older adults: a global initiative. Age Ageing. 2022 Sep 2;51(9):afac205. doi: 10.1093/ageing/afac205.

  PMID: 36178003 BACKGROUND

• Montero-Odasso MM, Kamkar N, Pieruccini-Faria F, Osman A, Sarquis-Adamson Y, Close J, Hogan DB, Hunter SW, Kenny RA, Lipsitz LA, Lord SR, Madden KM, Petrovic M, Ryg J, Speechley M, Sultana M, Tan MP, van der Velde N, Verghese J, Masud T; Task Force on Global Guidelines for Falls in Older Adults. Evaluation of Clinical Practice Guidelines on Fall Prevention and Management for Older Adults: A Systematic Review. JAMA Netw Open. 2021 Dec 1;4(12):e2138911. doi: 10.1001/jamanetworkopen.2021.38911.

  PMID: 34910151 BACKGROUND

• Ganz DA, Bao Y, Shekelle PG, Rubenstein LZ. Will my patient fall? JAMA. 2007 Jan 3;297(1):77-86. doi: 10.1001/jama.297.1.77.

  PMID: 17200478 BACKGROUND

• Park SH. Tools for assessing fall risk in the elderly: a systematic review and meta-analysis. Aging Clin Exp Res. 2018 Jan;30(1):1-16. doi: 10.1007/s40520-017-0749-0. Epub 2017 Apr 3.

  PMID: 28374345 BACKGROUND

• Burns ER, Lee R, Hodge SE, Pineau VJ, Welch B, Zhu M. Validation and comparison of fall screening tools for predicting future falls among older adults. Arch Gerontol Geriatr. 2022 Jul-Aug;101:104713. doi: 10.1016/j.archger.2022.104713. Epub 2022 Apr 30.

  PMID: 35526339 BACKGROUND

• Blain H, Annweiler C, Berrut G, Becker C, Bernard PL, Bousquet J, Dargent-Molina P, Friocourt P, Martin FC, Masud T, Petrovic M, Puisieux F, Robiaud JB, Ryg J, Van der Velde N, Montero-Odasso M, Rolland Y. [Synthesis in French of the 2022 global recommendations for the management and prevention of falls in the elderly]. Geriatr Psychol Neuropsychiatr Vieil. 2023 Jun 1;21(2):149-160. doi: 10.1684/pnv.2023.1108. French.

  PMID: 37519073 BACKGROUND

• Blain H, Annweiler C, Berrut G, Bernard PL, Bousquet J, Dargent-Molina P, Friocourt P, Puisieux F, Robiaud JB, Rolland Y. [Anti-fall plan for the elderly in France 2022-2024: objectives and methodology]. Geriatr Psychol Neuropsychiatr Vieil. 2023 Sep 1;21(3):286-294. doi: 10.1684/pnv.2023.1122. French.

  PMID: 38093564 BACKGROUND

• Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.

  PMID: 22972103 BACKGROUND

• Kendrick D, Kumar A, Carpenter H, Zijlstra GA, Skelton DA, Cook JR, Stevens Z, Belcher CM, Haworth D, Gawler SJ, Gage H, Masud T, Bowling A, Pearl M, Morris RW, Iliffe S, Delbaere K. Exercise for reducing fear of falling in older people living in the community. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD009848. doi: 10.1002/14651858.CD009848.pub2.

  PMID: 25432016 BACKGROUND

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jean Baptiste ROBIAUD, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Baptiste ROBIAUD, MD

CONTACT

+33629184092; jbrobiaud@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-centre, cross-sectional diagnostic

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: May 2, 2025
• Primary Completion: May 2, 2026
• Study Completion: May 2, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)