Construction, Validation, and Demonstration of a Comprehensive Prevention, Treatment, and Rehabilitation System for Toileting-Related Falls in Older Adults and People With Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of Participants Experiencing at Least One Toileting-Related Fall During Follow-up
研究概览
简要总结
Toileting-related falls may result from a combination of urinary symptoms, impaired gait and balance, reduced muscle strength, cognitive or emotional problems, and unsafe environmental conditions. Older adults and people with disabilities may be especially vulnerable because they frequently require assistance or must move quickly, particularly during nighttime toileting.
This multicenter prospective study will evaluate a comprehensive prevention, treatment, and rehabilitation program for older adults and people with disabilities who are at risk of toileting-related falls. Participants will receive a standardized multidimensional assessment covering urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, previous falls, and environmental risks.
Based on the risks identified, each participant will receive an individualized combination of interventions. These may include urinary symptom management, gait and balance rehabilitation, strength and mobility training, psychological or cognitive support, caregiver education, and modification of the toileting environment. Participants will be followed and reassessed, and their management plans may be adjusted according to changes in risk and clinical condition.
The study will evaluate the feasibility, implementation, and safety of this integrated care program, as well as changes in toileting-related falls, nighttime falls, urinary symptoms, mobility and balance, activities of daily living, and fear of falling.
详细描述
Toileting-related falls are clinically important events that may occur through the interaction of urinary urgency, nocturia, urinary incontinence, impaired mobility, gait and balance dysfunction, reduced muscle strength, cognitive or psychological problems, inadequate caregiver support, and environmental hazards. Conventional fall-prevention programs often focus mainly on mobility or environmental risks, whereas urinary symptoms and toileting-related exposure may not be addressed within the same care pathway.
This study is a multicenter, prospective, single-group interventional study designed to construct, validate, and demonstrate a comprehensive prevention, treatment, and rehabilitation system for toileting-related falls in older adults and people with disabilities. The study integrates urological care, rehabilitation, nursing, psychological support, caregiver involvement, environmental risk management, and longitudinal follow-up within a standardized dynamic management pathway.
The study pathway consists of the following stages:
- Participant screening and enrollment;
- Standardized multidimensional baseline assessment;
- Identification and stratification of modifiable risk factors;
- Development and delivery of an individualized multicomponent intervention plan;
- Follow-up and repeat assessment;
- Adjustment of the intervention plan based on clinical response, adherence, safety, and changes in risk;
- Feedback and continuous improvement of the implementation process.
The multidimensional assessment will cover the following major domains:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older, with no upper age limit.
- •Presence of physical disability, functional limitation, loss of independence, or a need for assistance with daily activities.
- •Presence of at least one risk factor for toileting-related falls, including but not limited to urinary frequency, urinary urgency, nocturia, urinary incontinence, voiding difficulty, overactive bladder, underactive bladder, impaired gait or balance, reduced muscle strength, fear of falling, cognitive or emotional problems, a history of falls, unsafe nighttime toileting, or environmental hazards associated with toileting.
- •Able and willing to participate in the study assessments and follow-up procedures, with assistance from a caregiver when necessary.
- •Written informed consent provided by the participant or, when applicable, by a legally authorized representative.
排除标准
- •Acute infection or other acute medical condition requiring immediate treatment that would prevent participation in study assessments or interventions.
- •Severe or unstable medical condition that, in the investigator's judgment, would make participation unsafe or interfere with study procedures or follow-up.
- •Severe disturbance of consciousness or other condition that prevents completion of the required assessments and study procedures, even with appropriate assistance.
- •Inability to participate in the planned follow-up or provide sufficient study-related information.
- •Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
结局指标
主要结局
Proportion of Participants Experiencing at Least One Toileting-Related Fall During Follow-up
时间窗: 6 months
The proportion of participants who experience at least one toileting-related fall during the follow-up period. A toileting-related fall is defined as a fall occurring in association with going to the toilet, using the toilet, transferring on or off the toilet, or returning from the toilet. The proportion will be calculated as the number of participants with at least one toileting-related fall divided by the total number of participants included in the follow-up analysis.
次要结局
- Number of Nighttime Toileting-Related Falls During the 6-Month Follow-up(6 months)
- Total Number of Falls During the 6-Month Follow-up(6 months)
- Change in Overactive Bladder Symptom Score From Baseline to 6 Months(Baseline and 6 months)
- Change in Average Number of Nocturia Episodes per Night From Baseline to 6 Months(Baseline and 6 months)
- Change in Tinetti Performance-Oriented Mobility Assessment Score From Baseline to 6 Months(Baseline and 6 months)
- Change in Modified Barthel Index From Baseline to 6 Months(Baseline and 6 months)
- Completion Rate of the Multidimensional Baseline Assessment(At baseline)
研究者
Qing Yuan
Chinese PLAGH
Chinese PLA General Hospital