[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590007":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":61,"collaborators":21,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":21,"enrollmentInfo":73,"targetDuration":21,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":89,"whyStopped":21,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University Hospital","Montpellier","Hérault","34090","France","FR",{"type":44,"coordinates":45},"Point",[46,47],3.87635,43.61093,{"lat":47,"lon":46},[50,54,58,59],{"name":51,"role":32,"phone":52,"phoneExt":53,"email":34},"Jean Baptiste Robiaud, MD","629184092","+33",{"name":55,"role":32,"phone":56,"phoneExt":53,"email":57},"Hubert Blain, MD PhD","681623432","h-blain@chu-montpellier.fr",{"name":51,"role":29,"phone":21,"phoneExt":21,"email":21},{"name":55,"role":60,"phone":21,"phoneExt":21,"email":21},"SUB_INVESTIGATOR",{"type":62,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100590007","validation-of-the-self-assessment-for-falls-in-the-elderly-safe-questionnaire-to-assess-the-risk-of-falls-in-people-aged-60-or-over-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":74,"type":75},300,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81,82],"Fall Prevention","Falls (Accidents) in Old Age",[84,85,86,87,88],"Falls","Functional Assessment","Predictive Value of Tests","Aging","Fallers Aged 60 Years and Older","NOT_YET_RECRUITING","2025-04-29",{"date":92,"type":93},"2025-05-08","ACTUAL",{"date":95,"type":75},"2025-05-02",{"date":97,"type":75},"2026-05-02",{"name":5,"class":6},1]