Integrated Prevention, Treatment, and Rehabilitation for Toileting-Related Falls

ConditionsToileting-Related Falls Fall Risk

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorQing Yuan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Individualized Multidimensional Management Program for Toileting-Related Fall Prevention
Other intervention
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

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: Integrated Multidimensional Management ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qing Yuan

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov

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