Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project

NCT07458958 | Recruiting DMC

• 1 other identifier: GZCDC-ECHR-2025P0088
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall; Old Age

Keywords

Cost-Effectiveness Analysis; Home Hazard Assessment and Modification; RCT; Community-Dwelling Older Adults; Fall Prevention

Outcome Measures

Primary Outcomes (1)

• The rate of falling in each group

  Falls will be monitored with supplied monthly fall diaries.

  Time Frame: Baseline, 6-month, 12-month]

Secondary Outcomes (4)

• Knowledge, Attitudes, and Practices (KAP) regarding Fall Prevention

  Time Frame: Baseline, 6-month, 12-month

• Fall efficacy in each group

  Time Frame: Baseline, 6-month, 12-month

• Quality of life in each group

  Time Frame: Baseline, 6-month, 12-month

• Timed Up and Go (TUG) Test

  Time Frame: Baseline, 6-month, 12-month

Study Arms (2)

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.

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.

Interventions

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.

Home Environment Assessment and Modification

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Center for Disease Control and Prevention: lead
• Southern Medical University, China: collaborator

Study Sites (1)

Guangzhoucenter Fordisease Control and Prevention（Guangzhou Health Supervision Institute）

Guangzhou, Guangdong, 510900, China

RECRUITING

Central Study Contacts

Run Doctor wang, Phd

CONTACT

+8619865182576; runwang@i.smu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Certainly. Here is a concise English summary of the blinding procedures described in the study protocol. This study employed a single-blind design. Due to the pragmatic nature of the intervention, which involved home environment assessments and the provision of physical aids, it was not feasible to blind the participating older adults or the personnel delivering the intervention. However, to minimize assessment bias, outcome assessors responsible for collecting follow-up data (e.g., fall incidents, questionnaire responses) and data analysts were blinded to the group allocation (intervention or control) throughout the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (1)