[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590007":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":60,"collaborators":21,"id":62,"slug":21,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":21,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":87,"whyStopped":21,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fall Risk Assessment","EXPERIMENTAL","Patients or carers over 60 consulting the geriatrics department at Montpellier University Hospital",[13,14],"Diagnostic Test: Questionnaire and Physical Exam","Diagnostic Test: Safe Self-Administered Questionnaire",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"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).\n\nThese 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.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Safe Self-Administered Questionnaire","All people who agree to take part in the study will first complete the SAFE self-questionnaire (intervention).\n\nthe 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).",[9],[27],{"name":28,"affiliation":5,"role":29},"Jean Baptiste ROBIAUD, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},"CONTACT","+33629184092","jbrobiaud@gmail.com",[36],{"facility":37,"status":21,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University Hospital","Montpellier","Hérault","34090","France",{"type":43,"coordinates":44},"Point",[45,46],3.87635,43.61093,{"lat":46,"lon":45},[49,53,57,58],{"name":50,"role":32,"phone":51,"phoneExt":52,"email":34},"Jean Baptiste Robiaud, MD","629184092","+33",{"name":54,"role":32,"phone":55,"phoneExt":52,"email":56},"Hubert Blain, MD PhD","681623432","h-blain@chu-montpellier.fr",{"name":50,"role":29,"phone":21,"phoneExt":21,"email":21},{"name":54,"role":59,"phone":21,"phoneExt":21,"email":21},"SUB_INVESTIGATOR",{"type":61,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100590007",false,"NCT06961812","Validation of the Self-Assessment for Falls in the Elderly (SAFE) Questionnaire to Assess the Risk of Falls in People Aged 60 or Over.","SAFE","Inclusion Criteria:\n\n* 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,\n* Able to perform the necessary physical assessments\n\nExclusion Criteria:\n\n* Unable, according to the investigator, to answer a self-questionnaire,\n* Patient's refusal to take part in the study\n* Absence of a caregiver if the participant is unable to answer the questionnaire alone\n* Unable to understand the information note\n* Opposition of the proxy or legal guardian if the participant is under legal protection (guardianship, curatorship, safeguard of justice)\n* Subject deprived of liberty (art. L. 1121-6) (by judicial or administrative decision, or forced hospitalization)\n* Not affiliated to a French social security scheme or beneficiary of such a scheme (L1121-8-1)\n* Participation in other research involving a period of exclusion still in progress (Article L1121-12)",true,"ALL","60 Years",{"count":72,"type":73},300,"ESTIMATED","INTERVENTIONAL",[76],"NA","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\u002Fno 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:\n\n* Eligibility: men or women ≥ 60 y, stable walking\u002Fbalance ≥ 1 month, able to read French and perform brief tests; legal guardianship or refusal excludes.\n* 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\n* Benefits\u002FRisks: instant personalised fall-risk feedback; SAFE is risk-free and physical tests carry only minimal supervised exertion.\n\nFalls 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.",[79,80],"Fall Prevention","Falls (Accidents) in Old Age",[82,83,84,85,86],"Falls","Functional Assessment","Predictive Value of Tests","Aging","Fallers Aged 60 Years and Older","NOT_YET_RECRUITING","2025-04-29",{"date":90,"type":91},"2025-05-08","ACTUAL",{"date":93,"type":73},"2025-05-02",{"date":95,"type":73},"2026-05-02",{"name":5,"class":6},1]