An interventional study of Individualized Multidimensional Management Program for Toileting-Related Fall Prevention in Toileting-Related Falls and Fall Risk, sponsored by Qing Yuan. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Qing Yuan · Not applicable, Interventional, and Prevention
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.
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:
The multidimensional assessment will cover the following major domains:
Urinary function: urinary frequency, urgency, nocturia, urinary incontinence, voiding difficulty, bladder-related symptoms, voiding diaries, and other clinically indicated urinary function measurements.
Gait, balance, and physical function: muscle strength, muscle tone, joint mobility, transfer ability, sit-to-stand performance, gait, balance, use of mobility aids, and fall risk.
Psychological and cognitive factors: fear of falling, anxiety, depressive symptoms, fall-related psychological responses, cognition, treatment cooperation, and caregiver support.
Activities of daily living and environmental risks: independence in toileting and other daily activities, nighttime lighting, the route from the bed to the toilet, slippery surfaces, handrails, toilet height, thresholds, availability of assistive devices, and caregiver response.
Interventions will be individualized according to the participant's predominant and modifiable risk factors. The intervention package may include behavioral and clinical management of urinary symptoms, bladder training, medication optimization when clinically appropriate, neuromodulation or electrical stimulation when indicated, gait and balance rehabilitation, muscle-strengthening and mobility training, transfer training, assistive-device adaptation, psychological or cognitive support, caregiver education, scheduled or assisted toileting, and modification of environmental hazards.
Not every participant will receive every intervention. The specific intervention combination will be selected according to the standardized assessment, clinical indications, participant needs, safety considerations, and available resources at each participating center.
Participants will undergo longitudinal follow-up to document intervention delivery, adherence, adverse events, repeat assessments, falls, toileting-related falls, nighttime falls, urinary symptoms, physical function, activities of daily living, and fear of falling. Intervention plans may be modified during follow-up when clinically indicated.
The study will assess both implementation outcomes and clinical outcomes. Implementation evaluation will include participant reach, institutional adoption, completion of standardized assessments, delivery of individualized interventions, protocol adherence, staff training, data completeness, follow-up completion, safety, and sustainability of the care pathway. Clinical evaluation will examine changes in toileting-related falls and related risk factors, including urinary symptoms, nocturia, gait and balance, functional independence, and fear of falling.
The overall aim is to determine whether this integrated and dynamically adjusted care pathway can be implemented safely and consistently across different clinical and rehabilitation settings and provide a reproducible model for the prevention and management of toileting-related falls.
Qing Yuan is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a comprehensive, individualized, multidimensional management program for the prevention of toileting-related falls. Following standardized assessment of urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, and environmental risks, participants will receive a tailored combination of interventions according to their identified risk factors and clinical indications. Interventions may include urinary symptom management, bladder training, medication optimization, neuromodulation or electrical stimulation when indicated, gait and balance rehabilitation, strength and mobility training, psychological or cognitive support, caregiver education, assisted or scheduled toileting, and environmental modification. Intervention plans may be adjusted during follow-up based on reassessment, clinical response, adherence, and safety.
Other: Individualized Multidimensional Management Program for Toileting-Related Fall Prevention
Participants will receive an individualized, multicomponent management program based on standardized multidimensional assessment and risk stratification. The assessment covers urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, caregiver support, and environmental risks related to toileting. The intervention plan will be tailored to each participant's identified modifiable risk factors and clinical indications. Components may include management of urinary symptoms and nocturia, bladder and behavioral training, clinically indicated treatment optimization, neuromodulation or electrical stimulation when appropriate, gait and balance rehabilitation, muscle-strengthening and mobility training, assistive-device adaptation, psychological or cognitive support, caregiver education, scheduled or assisted toileting, and environmental modification. Not all participants will receive every component. Intervention plans may be adju
Proportion of Participants Experiencing at Least One Toileting-Related Fall During Follow-up
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.
Time frame: 6 months
Number of Nighttime Toileting-Related Falls During the 6-Month Follow-up
The total number of nighttime toileting-related falls experienced by each participant during the 6-month follow-up period. A nighttime toileting-related fall is defined as a fall occurring during nighttime in association with going to the toilet, using the toilet, transferring on or off the toilet, or returning from the toilet.
Time frame: 6 months
Total Number of Falls During the 6-Month Follow-up
The total number of falls experienced by each participant during the 6-month follow-up period, regardless of whether the fall is related to toileting.
Time frame: 6 months
Change in Overactive Bladder Symptom Score From Baseline to 6 Months
Change in the Overactive Bladder Symptom Score (OABSS) from baseline to 6 months. The OABSS evaluates daytime urinary frequency, nocturia, urinary urgency, and urgency urinary incontinence. Total scores range from 0 to 15, with higher scores indicating more severe overactive bladder symptoms.
Time frame: Baseline and 6 months
Change in Average Number of Nocturia Episodes per Night From Baseline to 6 Months
Change in the average number of nocturnal voiding episodes per night from baseline to 6 months, assessed using participant-reported voiding records or voiding diaries. Nocturia is defined as waking from sleep to void during the nighttime period.
Time frame: Baseline and 6 months
Change in Tinetti Performance-Oriented Mobility Assessment Score From Baseline to 6 Months
Change in the total Tinetti Performance-Oriented Mobility Assessment score from baseline to 6 months. The assessment evaluates balance and gait performance. Higher scores indicate better mobility and a lower risk of falls.
Time frame: Baseline and 6 months
Change in Modified Barthel Index From Baseline to 6 Months
Change in the Modified Barthel Index from baseline to 6 months. The index assesses independence in activities of daily living, including personal care, toileting, mobility, transfers, and other daily activities. Higher scores indicate greater functional independence.
Time frame: Baseline and 6 months
Completion Rate of the Multidimensional Baseline Assessment
The proportion of enrolled participants who complete all protocol-required and applicable baseline assessment domains, including urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, fall history, and toileting-related environmental risks.
Time frame: At baseline
Enrollment Rate Among Eligible Screened Individuals
The proportion of eligible screened individuals who are enrolled in the study. The enrollment rate will be calculated as the number of participants enrolled divided by the total number of screened individuals who meet the study eligibility criteria, multiplied by 100.
Time frame: At completion of recruitment, up to 12 months after recruitment initiation
Proportion of Participants Receiving a Risk-Based Individualized Intervention
The proportion of enrolled participants who, after multidimensional assessment and risk stratification, receive at least one documented individualized intervention matched to their identified risk factors and clinical indications.
Time frame: Up to 6 months after enrollment
Six-Month Follow-up Completion Rate
The proportion of enrolled participants who complete the planned 6-month follow-up assessment. Completion requires documentation of the participant's follow-up status and collection of the core follow-up outcome data specified in the study protocol.
Time frame: At 6 months
Completeness of Required Study Data
The percentage of protocol-required data fields that are completed among all required data fields for enrolled participants. Data completeness will be assessed for baseline assessments, intervention records, follow-up records, and predefined study outcomes.
Time frame: Up to 6 months after enrollment
Plan to share: No
Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.
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