Fall PreventionSAFENCT06961812
Validation of the Self-Assessment for Falls in the Elderly (SAFE) Questionnaire to Assess the Risk of Falls in People Aged 60 or Over.
A study testing Questionnaire and Physical Exam and Safe Self-Administered Questionnaire in people with Fall Prevention and Falls (Accidents) in Old Age, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention, Falls (Accidents) in Old Age
- What is being tested?
- Questionnaire and Physical Exam and Safe Self-Administered Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2025to 2 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Participation in other research involving a period of exclusion still in progress (Article L1121-12)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital
Montpellier, Hérault, 34090
Jean Baptiste Robiaud, MD, 629184092 ext. +33, jbrobiaud@gmail.com
Hubert Blain, MD PhD, 681623432 ext. +33, h-blain@chu-montpellier.fr
About this study
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.
Read the detailed description
This single centre diagnostic accuracy study validates 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). SAFE is completed without assistance in ≈ 5 min and yields a continuous score that can be stratified into low, moderate, or high fall risk categories. The reference standard is the full guideline algorithm-Three Key Questions, detailed fall history characterisation, Timed Up and Go, Five Times Sit to Stand, 4 m gait speed, and Short Physical Performance Battery-administered by a trained clinician after the participant has returned the SAFE form to prevent incorporation bias.
The study adopts a cross sectional design and will recruit 300 community dwelling adults aged ≥ 60 years attending the Geriatrics Department of Montpellier University Hospital over 6 months. Sample size (300) was calculated for expected sensitivity and specificity of 0.85, 30 % prevalence of moderate to high fall risk, 5 % absolute precision, two sided α = 0.05, and 90 % power. After informed consent and eligibility verification, participants complete a single study visit in the following order: (1) SAFE self completion, (2) guideline interview plus physical tests. No investigational product, device, imaging, or biospecimen collection is involved.
Statistical plan. For every SAFE VAS (visual analogue scale) item, optimal cut points will be derived from non parametric ROC analysis versus its binary analogue. The primary analysis compares the three level SAFE classification with the reference standard using contingency tables and reports sensitivity, specificity, positive and negative predictive values, likelihood ratios, diagnostic odds ratio, and area under the summary ROC curve with 95 % confidence intervals. Secondary analyses will explore Pearson or point biserial correlations between individual SAFE scores and continuous physical test results, apply multivariable ordinal logistic regression to evaluate whether age, sex, or comorbidity modify SAFE performance, and perform decision curve analysis to estimate net clinical benefit across plausible threshold probabilities. Missing data will be handled by complete case analysis.
Data quality and monitoring. Source data will be captured in an electronic case report form with automated range and consistency checks. The CHU Montpellier sponsor will conduct risk based on site and/or remote monitoring and centralised statistical data surveillance. All study documentation will be archived for 15 years in line with French regulations.
Ethics, safety, and dissemination. The protocol has been submitted to a French Comité de Protection des Personnes and the Agence Nationale de Sécurité du Médicament (category 3). Physical testing is performed by certified staff in a dedicated fall prevention clinic with immediate assistance available; adverse events are therefore not expected but will be recorded and reported according to Good Clinical Practice. Results-positive, negative, or inconclusive-will be published in peer reviewed journals and communicated to participants on request. Should SAFE demonstrate acceptable diagnostic accuracy, its simplicity will enable large scale, low cost self screening, integration into mobile health applications, and targeted allocation of fall prevention resources for older adults.
- Conditions
- Fall Prevention, Falls (Accidents) in Old Age
- Being tested
- Questionnaire and Physical Exam, Safe Self-Administered Questionnaire
- Keywords
- Falls, Functional Assessment, Predictive Value of Tests, Aging, Fallers Aged 60 Years and Older
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamDiagnostic 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.
Safe Self-Administered QuestionnaireDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Fall Risk Assessment | Experimental | Patients or carers over 60 consulting the geriatrics department at Montpellier University Hospital Receives: Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: Safe Self-Administered Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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,
Measured: 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
Measured: 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
Measured: 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
Measured: At inclusion
Secondary outcomes (4)
VAS thresholds for the self-questionnaire
In this section, for each binary question on the hetero-questionnaire or involving a physical test, we aim to determine a VAS threshold from the self-questionnaire for the corresponding question. The hetero-questionnaire measure is used as a reference measure: fear of falling, unsteadiness when standing up, unsteadiness when walking, getting up easily from a chair without using hands, walking speed, fatigue, reduction in physical activity.
Measured: At inclusion
Concordance analyses
We wish to evaluate the concordance between the SAFE self-questionnaire responses and the global recommendations algorithm hetero-assessment via the Gwet coefficient for qualitative variables and the intra-class correlation coefficient (ICC) for quantitative variables.
Measured: At inclusion
Point-biserial correlations
We wish to evaluate the correlation between the VAS of the self-questionnaire and the dichotomous variables of the hetero-questionnaire (point-biserial correlations).
Measured: At inclusion
Pearson correlation analysis
We wish to evaluate the correlation between the VAS of the self-questionnaire and the physical tests of the hetero-questionnaire (Pearson correlations).
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start2 May 2025 (estimated)
- Primary completion2 May 2026 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fall PreventionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-centre, cross-sectional diagnostic
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Baptiste ROBIAUD, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961812
- Sponsor's protocol ID
- REHCMPL25_0035
- Acronym
- SAFE
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36178003Montero-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.
PubMed 34910151Ganz 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.
PubMed 17200478Park 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.
PubMed 28374345Burns 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.
PubMed 35526339Blain 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.
PubMed 37519073Blain 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.
PubMed 38093564Gillespie 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.
PubMed 22972103Kendrick 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.
PubMed 25432016
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Self-Assessment for Falls in the Elderly (SAFE) Questionnaire to Assess the Risk of Falls in People Aged 60 or Over.
- ClinicalTrials.gov ID
- NCT06961812
- Acronym / sponsor ID
- SAFE / REHCMPL25_0035
- Conditions
- Fall Prevention, Falls (Accidents) in Old Age
- Keywords
- Falls, Functional Assessment, Predictive Value of Tests, Aging, Fallers Aged 60 Years and Older
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 May 2025 (estimated)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single centre diagnostic accuracy study validates 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). SAFE is completed without assistance in ≈ 5 min and yields a continuous score that can be stratified into low, moderate, or high fall risk categories. The reference standard is the full guideline algorithm-Three Key Questions, detailed fall history characterisation, Timed Up and Go, Five Times Sit to Stand, 4 m gait speed, and Short Physical Performance Battery-administered by a trained clinician after the participant has returned the SAFE form to prevent incorporation bias.
The study adopts a cross sectional design and will recruit 300 community dwelling adults aged ≥ 60 years attending the Geriatrics Department of Montpellier University Hospital over 6 months. Sample size (300) was calculated for expected sensitivity and specificity of 0.85, 30 % prevalence of moderate to high fall risk, 5 % absolute precision, two sided α = 0.05, and 90 % power. After informed consent and eligibility verification, participants complete a single study visit in the following order: (1) SAFE self completion, (2) guideline interview plus physical tests. No investigational product, device, imaging, or biospecimen collection is involved.
Statistical plan. For every SAFE VAS (visual analogue scale) item, optimal cut points will be derived from non parametric ROC analysis versus its binary analogue. The primary analysis compares the three level SAFE classification with the reference standard using contingency tables and reports sensitivity, specificity, positive and negative predictive values, likelihood ratios, diagnostic odds ratio, and area under the summary ROC curve with 95 % confidence intervals. Secondary analyses will explore Pearson or point biserial correlations between individual SAFE scores and continuous physical test results, apply multivariable ordinal logistic regression to evaluate whether age, sex, or comorbidity modify SAFE performance, and perform decision curve analysis to estimate net clinical benefit across plausible threshold probabilities. Missing data will be handled by complete case analysis.
Data quality and monitoring. Source data will be captured in an electronic case report form with automated range and consistency checks. The CHU Montpellier sponsor will conduct risk based on site and/or remote monitoring and centralised statistical data surveillance. All study documentation will be archived for 15 years in line with French regulations.
Ethics, safety, and dissemination. The protocol has been submitted to a French Comité de Protection des Personnes and the Agence Nationale de Sécurité du Médicament (category 3). Physical testing is performed by certified staff in a dedicated fall prevention clinic with immediate assistance available; adverse events are therefore not expected but will be recorded and reported according to Good Clinical Practice. Results-positive, negative, or inconclusive-will be published in peer reviewed journals and communicated to participants on request. Should SAFE demonstrate acceptable diagnostic accuracy, its simplicity will enable large scale, low cost self screening, integration into mobile health applications, and targeted allocation of fall prevention resources for older adults.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-centre, cross-sectional diagnostic
| Arm | Type | Receives |
|---|---|---|
| Fall Risk Assessment | Experimental | Diagnostic Test: Questionnaire and Physical Exam, Diagnostic Test: Safe Self-Administered QuestionnairePatients or carers over 60 consulting the geriatrics department at Montpellier University Hospital |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamNext, 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 | Fall Risk Assessment |
| Safe Self-Administered QuestionnaireAll 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). | Diagnostic test | Fall Risk Assessment |
Primary outcome
Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). sensitivity
Time frame: At inclusion
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
Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). specificity
Time frame: At inclusion
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
Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). positive predictive values
Time frame: At inclusion
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,
Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). negative predictive values
Time frame: At inclusion
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
Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). likelihood ratios
Time frame: At inclusion
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
Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). diagnostic odds ratio
Time frame: At inclusion
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
4 secondary outcomes
VAS thresholds for the self-questionnaire
Time frame: At inclusion
Concordance analyses
Time frame: At inclusion
Point-biserial correlations
Time frame: At inclusion
Pearson correlation analysis
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Background: PubMed 36178003Montero-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.
- Background: PubMed 34910151Montero-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.
- Background: PubMed 17200478Ganz 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.
- Background: PubMed 28374345Park 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.
- Background: PubMed 35526339Burns 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.
- Background: PubMed 37519073Blain 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.
- Background: PubMed 38093564Blain 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.
- Background: PubMed 22972103Gillespie 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.
- Background: PubMed 25432016Kendrick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Baptiste ROBIAUD, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and Physical Exam and Safe Self-Administered Questionnaire in people with Fall Prevention and Falls (Accidents) in Old Age, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Baptiste ROBIAUD, MD (+33629184092, jbrobiaud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the SAFE Self-Assessment Questionnaire compared with the global recommendations algorithm (Hetero-administered questionnaire and physical tests). sensitivity (time frame: At inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06961812, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.