Integrated Prevention, Treatment, and Rehabilitation for Toileting-Related Falls
Construction, Validation, and Demonstration of a Comprehensive Prevention, Treatment, and Rehabilitation System for Toileting-Related Falls in Older Adults and People With Disabilities
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qing Yuan, MD, PhD
- Phone Number: +8618910980422
- Email: qyuanmd@outlook.com
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100039
- Chinese PLA General Hospital
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Contact:
- Qing Yuan, MD, PhD
- Phone Number: +8618910980422
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated Multidimensional Management Program
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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants Experiencing at Least One Toileting-Related Fall During Follow-up
Time Frame: 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.
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Nighttime Toileting-Related Falls During the 6-Month Follow-up
Time Frame: 6 months
|
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.
|
6 months
|
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Total Number of Falls During the 6-Month Follow-up
Time Frame: 6 months
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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.
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6 months
|
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Change in Overactive Bladder Symptom Score From Baseline to 6 Months
Time Frame: Baseline and 6 months
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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.
|
Baseline and 6 months
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Change in Average Number of Nocturia Episodes per Night From Baseline to 6 Months
Time Frame: Baseline and 6 months
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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.
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Baseline and 6 months
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Change in Tinetti Performance-Oriented Mobility Assessment Score From Baseline to 6 Months
Time Frame: Baseline and 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.
|
Baseline and 6 months
|
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Change in Modified Barthel Index From Baseline to 6 Months
Time Frame: Baseline and 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.
|
Baseline and 6 months
|
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Completion Rate of the Multidimensional Baseline Assessment
Time Frame: At baseline
|
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.
|
At baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment Rate Among Eligible Screened Individuals
Time Frame: At completion of recruitment, up to 12 months after recruitment initiation
|
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.
|
At completion of recruitment, up to 12 months after recruitment initiation
|
|
Proportion of Participants Receiving a Risk-Based Individualized Intervention
Time Frame: Up to 6 months after enrollment
|
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.
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Up to 6 months after enrollment
|
|
Six-Month Follow-up Completion Rate
Time Frame: At 6 months
|
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.
|
At 6 months
|
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Completeness of Required Study Data
Time Frame: Up to 6 months after enrollment
|
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.
|
Up to 6 months after enrollment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Eckstrom E, Parker EM, Lambert GH, Winkler G, Dowler D, Casey CM. Implementing STEADI in Academic Primary Care to Address Older Adult Fall Risk. Innov Aging. 2017 Sep;1(2):igx028. doi: 10.1093/geroni/igx028.
- Szabo SM, Gooch KL, Walker DR, Johnston KM, Wagg AS. The Association Between Overactive Bladder and Falls and Fractures: A Systematic Review. Adv Ther. 2018 Nov;35(11):1831-1841. doi: 10.1007/s12325-018-0796-8. Epub 2018 Sep 25.
- Vaughan CP, Brown CJ, Goode PS, Burgio KL, Allman RM, Johnson TM 2nd. The association of nocturia with incident falls in an elderly community-dwelling cohort. Int J Clin Pract. 2010 Apr;64(5):577-83. doi: 10.1111/j.1742-1241.2009.02326.x.
- Zou M, Lu R, Jiang Y, Liu P, Tian B, Liang Y, Wang X, Jiang L. Association between toileting and falls in older adults admitted to the emergency department and hospitalised: a cross-sectional study. BMJ Open. 2023 Jun 1;13(6):e065544. doi: 10.1136/bmjopen-2022-065544.
- Rose G, Decalf V, Everaert K, Bower WF. Toileting-related falls at night in hospitalised patients: The role of nocturia. Australas J Ageing. 2020 Mar;39(1):e70-e76. doi: 10.1111/ajag.12696. Epub 2019 Jul 18.
- Montero-Odasso M, van der Velde N, Martin FC, Petrovic M, Tan MP, Ryg J, Aguilar-Navarro S, Alexander NB, Becker C, Blain H, Bourke R, Cameron ID, Camicioli R, Clemson L, Close J, Delbaere K, Duan L, Duque G, Dyer SM, Freiberger E, Ganz DA, Gomez F, Hausdorff JM, Hogan DB, Hunter SMW, Jauregui JR, Kamkar N, Kenny RA, Lamb SE, Latham NK, Lipsitz LA, Liu-Ambrose T, Logan P, Lord SR, Mallet L, Marsh D, Milisen K, Moctezuma-Gallegos R, Morris ME, Nieuwboer A, Perracini MR, Pieruccini-Faria F, Pighills A, Said C, Sejdic E, Sherrington C, Skelton DA, Dsouza S, Speechley M, Stark S, Todd C, Troen BR, van der Cammen T, Verghese J, Vlaeyen E, Watt JA, Masud T; Task Force on Global Guidelines for Falls in Older Adults. World guidelines for falls prevention and management for older adults: a global initiative. Age Ageing. 2022 Sep 2;51(9):afac205. doi: 10.1093/ageing/afac205.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PLAGH-TOILETFALL-2023-750
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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