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NCT Number: NCT07458958

Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project

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.

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Key information

Conditions

Fall Old Age

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhoucenter Fordisease Control and Prevention（Guangzhou Health Supervision Institute）

Guangzhou, Guangdong, 510900, China

Location status: Recruiting

Location contact

tingyuan huang, Phd

CONTACT

[email protected]

+8618565238524

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home Environment Assessment and Modification

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Run Doctor wang, Phd

CONTACT

[email protected]

+8619865182576

Sponsors and collaborators

Lead sponsor

Guangzhou Center for Disease Control and Prevention

Other Gov

Collaborators

  • Southern Medical University, China

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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