- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458958
Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Run Doctor wang, Phd
- Phone Number: +8619865182576
- Email: runwang@i.smu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510900
- Recruiting
- Guangzhoucenter Fordisease Control and Prevention(Guangzhou Health Supervision Institute)
-
Contact:
- tingyuan huang, Phd
- Phone Number: +8618565238524
- Email: 41165996@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 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.
|
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 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.
|
|
No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of falling in each group
Time Frame: Time Frame: Baseline, 6-month, 12-month]
|
Falls will be monitored with supplied monthly fall diaries.
|
Time Frame: Baseline, 6-month, 12-month]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge, Attitudes, and Practices (KAP) regarding Fall Prevention
Time Frame: Time Frame: Baseline, 6-month, 12-month
|
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
Time Frame: Time Frame: Baseline, 6-month, 12-month
|
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
Time Frame: Time Frame: Baseline, 6-month, 12-month
|
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
Time Frame: Time Frame: Baseline, 6-month, 12-month
|
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
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GZCDC-ECHR-2025P0088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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