Efficacy of a Multifactorial and Personalized Program for Fall Prevention in Community-dwelling Elderly in Comparison to the Usual Care: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 2
- 主要终点
- Fall rate at 12 months from enrolment
研究概览
简要总结
Randomized Controlled Trial (RCT) aiming at assessing the efficacy of an interdisciplinary multi-component and personalized multi-factorial intervention for reducing falls at one year post-enrolment in comparison to the usual care in a sample of community dwelling elderly (age ≥65 years), with or without Parkinson's Disease and/or previous Stroke.
详细描述
BACKGROUND: Current literature on fall prevention for community-dwelling elderly who are at risk of falling suggests that: 1) either single, multicomponent or multifactorial interventions are effective at preventing falls; 2) elderly at risk of falling with Parkinson's Disease (PD) and previous Stroke, although having an even greater risk of falling, are often excluded by these interventions; 3) often, present screening methods for risk of falling do not allow the early identification of subjects at risk before the first fall.
AIMS
- To compare the efficacy of an interdisciplinary multicomponent and personalized multifactorial intervention aiming at reducing falls in comparison to the usual care, in a sample of community dwelling elderly, with or without Parkinson's Disease and/or previous Stroke, within the context of an RCT.
- To improve the accuracy of screening tests for risk of falling by using wearable inertial sensors.
- To develop a reduced set of clinical and instrumental indicators, to be utilized as a quick and reliable screening tests in outpatients clinics.
METHODS: multicenter, randomized controller trial, with blind assessments on pretest, postest and on one-year follow-up.
POPULATION: community-dwelling elderly (aged ≥65 years) with age-related or neurological condition-related (Parkinson's Disease and/or Stroke) risk of falling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling elderly (aged ≥65 years)
- •Moderate to high fall risk, either associated to aging or to neurological diseases as Parkinson's Disease and stroke.
- •Ability to walk 10 meters without assistance (walking aid permitted)
- •Informed consent to participation
排除标准
- •Whatever concurrent medical condition which may constitutes a contraindication to physical exercise
- •Known cognitive decline or an established diagnosis of dementia (mini mental score >24) or an evident cognitive decline on pre-enrolment which would be likely to impair the ability of comprehension of simple instructions and / or of collaborating
- •Severe hearing impairment, so that a subject will not understand less than 80% of ordinary conversation with/or without hearing aids.
- •Severe hypovision, not counteracted by lenses, which will limit the patient in executing at least one activity of daily living (for instance, necessity of assistance for walking because of visual deficit).
- •Severe aphasia or visuo-spatial deficits, to the extent that these impairments will limit significantly the ability to comprehend (orally or visually) simple instructions.
- •Acute vertigo or dizziness lasting less than 3 months
- •Regular participation to other exercise program that it is likely to challenge balance, including physical therapy.
研究组 & 干预措施
Interdisciplinary interventions
Multicomponent interventions
- On-site supervised group exercise program (11 weeks)
- Educational / behavioral sessions addressing specific behavioral and environmental risk factors for falls delivered by trained health professionals (11 sessions in total)
- Home visits for suggestion and implementations of safety interventions aiming at reducing environmental hazards
- Home-based exercise program: Personalized multi-factorial interventions: patients will have geriatric, neurology and physiatrist outpatient referrals to assess and treat individual risk factors.
Personalized multi-factorial interventions. Patients will have geriatric, neurology and physiatrist outpatient referrals to assess and treat individual risk factors
干预措施: Interdisciplinary multicomponent interventions (Behavioral)
Usual care
Usual care: after pre-test assessment and randomization, participants in the control group will be given a structured booklet with detailed information about participant's own personal risk factors (fall risk profile) to be given to the family doctor, together with an information booklet on fall risk factors and their prevention.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Fall rate at 12 months from enrolment
时间窗: Months 1 - Months 12
The primary endpoint will be the total number of falls (fall rate) occurred in each arm within 12 months from enrolment. This endpoint will be recorded by participants in a fall diary (which will be collected from each participant at month 12). Recorded information in the fall diary will be monitored monthly with follow-up calls
次要结局
- Risk of falling at 12 months from enrolment(Months 1 - Months 12)
- Percentage of falls associated to hospital admission at 12 months from enrolment(Months 1 - Months 12)
- Severity of the fall(Months 1 - Months 12)
- Mortality attributable to fall(Months 1 - Months 12)
- Fall-free interval time(Months 1 - Months 12)
- Total number of A&E accesses attributable to falls(Months 1 - Months 12)
- Risk of A&E access attributable to falls(Months 1 - Months 12)
- Length of stay as inpatient attributable to falls(Months 1 - Months 12)