About this trial
This Guangzhou-based project uses a randomized controlled trial to test home environment modifications (e.g., anti-slip mats, lighting) for preventing falls among 320 community-dwelling elders. Over 12 months, it assesses effectiveness, cost-efficiency, and scalability, with rigorous quality control and multi-level stakeholder collaboration.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between 60 and 80 years old (inclusive).
Community-dwelling.
Planning to reside at the current address for the next 12 months.
Able to walk 50 meters unaided (can use a cane).
Disqualifiers
Having an acute disease or an acute episode of a chronic disease.
Having hearing, vision, or cognitive impairments, or self-reported neurological or psychiatric diseases (e.g., epilepsy, dementia) that prevent normal communication and learning.
Self-reported serious diseases (e.g., cardiac, cerebral, renal, hepatic, respiratory, or hematologic systems) and judged by a doctor or on-site assessor as intolerant to physical activity.
Diagnosed with conditions that explicitly affect balance function (e.g., vestibular disorders, cerebellar system lesions, vertigo, Ménière's disease).
Trial design
Parallel
Treatments tested in this trial
Home Environment Assessment and Modification
BehavioralParticipants randomized to this arm receive a multi-component intervention. A trained community health worker conducts a one-time, comprehensive in-home assessment of fall hazards using a standardized checklist. Based on the assessment, the participant receives personalized, face-to-face advice for environmental modifications and is provided with, and instructed on the use of, essential safety aids including non-slip mats, night lights, anti-fall warning signs, and double-sided tape (for securing rugs). This core intervention is delivered once, 4-6 weeks after the baseline survey. All participants (in both arms) are followed up monthly for 12 months to collect data on falls.
Treatment groups
Trial outcomes
Primary outcomes
The rate of falling in each group
Falls will be monitored with supplied monthly fall diaries.
Secondary outcomes
Knowledge, Attitudes, and Practices (KAP) regarding Fall Prevention
Measuring Knowledge, Attitudes, and Practices (KAP) regarding fall using a self-administered questionnaire. Regarding the questionnaire measurement section, we would like to clarify that the Knowledge, Attitude, and Practices (KAP) survey in our study was scored and assessed as a holistic construct or a composite measure. The overall KAP score was used for primary reporting and statistical analysis, rather than treating Knowledge (K), Attitude (A), and Practices (P) as three independent, separately analyzed dimensions or subscales.
Fall efficacy in each group
Fall efficacy will be monitored with 'Falls Efficacy Scale International, FES-I', and each item is scored on a scale of 1 to 4 (from "not at all confident" to "very confident"), with a total score of 16 to 64, with higher scores indicating a greater sense of fall efficacy or self-confidence.
Quality of life in each group
Quality of life will be monitored with 'the 12-item MOS Short-form Health Survey version 2, SF-12 V.2'. All entries except 1, 8, 9 and 10 are positively scored and the total score is calculated by the scale's unique standardised method, with a minimum score of 0 and a maximum score of 100
Timed Up and Go (TUG) Test
Description: The Timed Up and Go (TUG) Test is a simple, performance-based assessment of functional mobility, dynamic balance, and fall risk. It measures the time (in seconds) a person takes to stand up from a standard chair, walk 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down again. Key Metrics: Score Range: The result is a continuous time measurement in seconds. There is no predefined minimum or maximum score, as it is a timed test. Interpretation: A higher score (longer time) indicates worse performance-specifically, greater mobility impairment, higher fall risk, and reduced functional independence. Common Clinical Cut-off: While not a strict maximum, a time of ≥10 seconds for community-dwelling older adults is often used as a clinical indicator of potential mobility limitations and increased fall risk. Times significantly above 10-12 seconds suggest higher impairment.
Sponsors and contacts
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Guangzhou Center for Disease Control and Prevention
Lead sponsor
Southern Medical University, China
Collaborator