Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The rate of falling in each group
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Home Environment Assessment and Modification (Behavioral)
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.
结局指标
主要结局
The rate of falling in each group
时间窗: Time Frame: Baseline, 6-month, 12-month]
Falls will be monitored with supplied monthly fall diaries.
次要结局
- 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)