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

Официальное название

Construction, Validation, and Demonstration of a Comprehensive Prevention, Treatment, and Rehabilitation System for Toileting-Related Falls in Older Adults and People With Disabilities

Обзор

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.

Подробное описание

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:

1. Participant screening and enrollment; 2. Standardized multidimensional baseline assessment; 3. Identification and stratification of modifiable risk factors; 4. Development and delivery of an individualized multicomponent intervention plan; 5. Follow-up and repeat assessment; 6. Adjustment of the intervention plan based on clinical response, adherence, safety, and changes in risk; 7. 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.

Вмешательства

• Другое 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 i

Первичные конечные точки

• Proportion of Participants Experiencing at Least One Toileting-Related Fall During Follow-up [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Number of Nighttime Toileting-Related Falls During the 6-Month Follow-up [Срок оценки: 6 months]
• Total Number of Falls During the 6-Month Follow-up [Срок оценки: 6 months]
• Change in Overactive Bladder Symptom Score From Baseline to 6 Months [Срок оценки: Baseline and 6 months]
• Change in Average Number of Nocturia Episodes per Night From Baseline to 6 Months [Срок оценки: Baseline and 6 months]
• Change in Tinetti Performance-Oriented Mobility Assessment Score From Baseline to 6 Months [Срок оценки: Baseline and 6 months]
• Change in Modified Barthel Index From Baseline to 6 Months [Срок оценки: Baseline and 6 months]
• Completion Rate of the Multidimensional Baseline Assessment [Срок оценки: At baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Публикации

• 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. PMID 29955671
• 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. PMID 30255417
• 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. PMID 20456212
• 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. PMID 37263694
• 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. PMID 31321899
• 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 PMID 36178003

Идентификаторы

NCT: NCT07738354 · PLAGH-TOILETFALL-2023-750

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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