FallNCT07458958
Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project
A study testing Home Environment Assessment and Modification in people with Fall and Old Age, run by Guangzhou Center for Disease Control and Prevention at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Home Environment Assessment and Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhoucenter Fordisease Control and Prevention（Guangzhou Health Supervision Institute）
Guangzhou, Guangdong, 510900
tingyuan huang, Phd, +8618565238524, 41165996@qq.com
About this study
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.
- Being tested
- Home Environment Assessment and Modification
- Keywords
- Cost-Effectiveness Analysis, Home Hazard Assessment and Modification, RCT, Community-Dwelling Older Adults, Fall Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Environment Assessment and ModificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Environment Assessment and Modification | Experimental | 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. Receives: Behavioral: Home Environment Assessment and Modification |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The rate of falling in each group
Falls will be monitored with supplied monthly fall diaries.
Measured: Time Frame: Baseline, 6-month, 12-month]
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Time Frame: Baseline, 6-month, 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jan 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Title: A Cluster Randomized Controlled Trial of Home Environment Assessment and Modification for Fall Prevention among Community-Dwelling Older Adults in Guangzhou, China 1. Study Design A two-arm, parallel-group, cluster randomized controlled trial (RCT) with a 12-month follow-up period. 2. Primary Objective To evaluate the effectiveness of a home environment assessment and modification intervention in reducing the incidence of falls among community-dwelling older adults, compared to a no-intervention control. 3. Participants and Setting Target Population: 320 community-dwelling adults aged 60-80 years. Setting: 8 Community Health Centers (CHCs) in Huadu District, Guangzhou. Inclusion Criteria: Able to walk 50 meters unaided, planning to reside in the current address for the next 12 months. Exclusion Criteria: Acute illness, unwilling to complete the 12-month follow-up. 4. Intervention Intervention Group: Receives a one-time, comprehensive home environment fall hazard
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- Southern Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458958
- Sponsor's protocol ID
- GZCDC-ECHR-2025P0088
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project
- ClinicalTrials.gov ID
- NCT07458958
- Acronym / sponsor ID
- GZCDC-ECHR-2025P0088
- Keywords
- Cost-Effectiveness Analysis, Home Hazard Assessment and Modification, RCT, Community-Dwelling Older Adults, Fall Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Guangzhou Center for Disease Control and PreventionOther government
- Collaborators
- Southern Medical University, China
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Title: A Cluster Randomized Controlled Trial of Home Environment Assessment and Modification for Fall Prevention among Community-Dwelling Older Adults in Guangzhou, China 1. Study Design A two-arm, parallel-group, cluster randomized controlled trial (RCT) with a 12-month follow-up period. 2. Primary Objective To evaluate the effectiveness of a home environment assessment and modification intervention in reducing the incidence of falls among community-dwelling older adults, compared to a no-intervention control. 3. Participants and Setting Target Population: 320 community-dwelling adults aged 60-80 years. Setting: 8 Community Health Centers (CHCs) in Huadu District, Guangzhou. Inclusion Criteria: Able to walk 50 meters unaided, planning to reside in the current address for the next 12 months. Exclusion Criteria: Acute illness, unwilling to complete the 12-month follow-up. 4. Intervention Intervention Group: Receives a one-time, comprehensive home environment fall hazard
| Arm | Type | Receives |
|---|---|---|
| Home Environment Assessment and Modification | Experimental | Behavioral: Home Environment Assessment and ModificationParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Environment Assessment and ModificationParticipants 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. | Behavioural | Home Environment Assessment and Modification |
Primary outcome
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.
4 secondary outcomes
Knowledge, Attitudes, and Practices (KAP) regarding Fall Prevention
Time frame: Time Frame: Baseline, 6-month, 12-month
Fall efficacy in each group
Time frame: Time Frame: Baseline, 6-month, 12-month
Quality of life in each group
Time frame: Time Frame: Baseline, 6-month, 12-month
Timed Up and Go (TUG) Test
Time frame: Time Frame: Baseline, 6-month, 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Fall
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruitingObservational study
Perception of Action Opportunities for Obstacle Crossing in Parkinson's Disease
PARKINSON DISEASE (Disorder), Older Adults (65-85 Years)
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Environment Assessment and Modification in people with Fall and Old Age, run by Guangzhou Center for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Run Doctor wang, Phd (+8619865182576, runwang@i.smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of falling in each group (time frame: Time Frame: Baseline, 6-month, 12-month]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.