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Clinical Trial NCT07458958 for Fall, Old Age is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project 320 Randomized Senior-Focused Prevention
Clinical Trial NCT07458958 is an interventional study for Fall, Old Age that is recruiting. It started on 1 January 2026 with plans to enroll 320 participants. Led by Guangzhou Center for Disease Control and Prevention, it is expected to complete by 1 February 2027. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
Brief Summary
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.
Official Title
Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project
Conditions
FallOld AgeOther Study IDs
- GZCDC-ECHR-2025P0088
NCT ID Number
Start Date (Actual)
2026-01-01
Last Update Posted
2026-03-23
Completion Date (Estimated)
2027-02-01
Enrollment (Estimated)
320
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Cost-Effectiveness Analysis
Home Hazard Assessment and Modification
RCT
Community-Dwelling Older Adults
Fall Prevention
Home Hazard Assessment and Modification
RCT
Community-Dwelling Older Adults
Fall Prevention
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHome Environment Assessment and Modification Participants 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...Show More | Home Environment Assessment and Modification Participants 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...Show More |
No InterventionControl Participants randomized to this arm do not receive the home environment assessment, modification advice, or any safety aids. They continue with their usual activities. To ensure balanced data collection, they undergo identical baseline and outcome assessments (at 6 and 12 months) as the intervention group, and their falls are similarly tracked via monthly fall calendars for the 12-month study period. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The rate of falling in each group | Falls will be monitored with supplied monthly fall diaries. | Time Frame: Baseline, 6-month, 12-month] |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Time Frame: Baseline, 6-month, 12-month |
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. | Time Frame: Baseline, 6-month, 12-month |
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 | Time Frame: Baseline, 6-month, 12-month |
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. | Time Frame: Baseline, 6-month, 12-month |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
60 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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).
- Experienced one or more falls in the past 2 years, OR Is "very worried" or "somewhat worried" about falling (even without a fall history).
- Willing to participate in the 12-month fall prevention program and follow-up assessments.
- Possesses basic literacy skills (equivalent to elementary school level or above) and is capable of normal communication with the investigators, as judged by the staff.
- In a stable health condition to participate, as determined by the investigator.
- 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).
- Requires a wheelchair or assistance from another person to walk.
- Likely to move away from the current residence or be absent for an extended period within the next 6 months.
- Unwilling to accept the 12-month follow-up.
Guangzhou Center for Disease Control and PreventionSouthern Medical University, China308 active studies to exploreStudy Central Contact
Contact: Run Doctor wang, Phd, +8619865182576, [email protected]
1 Study Locations in 1 Countries
Guangdong
Guangzhoucenter Fordisease Control and Prevention（Guangzhou Health Supervision Institute）, Guangzhou, Guangdong, 510900, China
tingyuan huang, Phd, Contact, +8618565238524, [email protected]
Recruiting