Randomized Controlled Trial to Reduce Falls Incidence Rate in Frail Elderly
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- Falls incidence rate
研究概览
简要总结
Background: Approximately 750,000 elderly Dutch people fall at least once a year, which often results in physical injuries and a fear of falling, with high costs and far-reaching consequences on functionality, physical activity, quality of life and mental well-being. Falling is not only a burden for patients, it is also a burden for their caregivers. Recurrent falling is a complex problem. However, the pathophysiological background of falls, gait problems and dementia is largely unknown. The general pathophysiological hallmark of aging is a liability in homeostatic mechanisms of organs. This liability results in an impaired ability to adapt to stress and in increased biological variation in outcome measures within individuals. In this study the investigators aim at developing an intervention to reduce recurrent falling in frail elderly fallers.
Hypotheses: The investigators hypothesize that the intervention program will decrease the number of falls and fear of falling and increase mental well-being, physical activity and functional performance in frail elderly people with a history of recurrent falling. In addition, the burden on the caregivers will be reduced due to the intervention and will be cost-effective. Furthermore, the investigators hypothesize that patients with a high short-term intra-individual biological variability in gait and cognition variables have a higher risk of falling, worse gait performance and cognitive decline after long term follow-up.
Study Design: Randomized, controlled, single-blind trial.
Study Population: 160 patients referred to a geriatric outpatient clinic, who fell at least once in the last 6 months and their primary caregivers (N=160).
Intervention: A multifaceted fall prevention program for frail elders to reduce falls incidence rate, consisting of physical and cognitive components. Moreover, it includes a training program for caregivers in which they learn to support and give advice to the patients, aiming to decrease the burden on the caregivers.
Primary Outcome Measures: The fall incidence rate is the primary outcome measure. Total observation time of falls will be 6 months after the start of the intervention.
Secondary Outcome Measures: In the patients, the secondary outcome measures are fear of falling (FES), quality of life (MOS-20), depression and general anxiety, functional performance in activities of daily living, physical activity, mobility, gait parameters, body sway and biomarkers of endothelial function and frailty. For the caregiver, the secondary outcome measures are caregiver's burden, mood and quality of life. In addition, intraindividual variability of cognition, balance and gait in both patients and caregivers, will be assessed and cost-effectiveness of the intervention will also be determined.
详细描述
Nature and Extent of the Burden and Risks Associated with Participation, Benefit and Group Relatedness: The outcome of this study may have important reflections on protocols to prevent falling among elders and on health care decision makers to stimulate starting new fall clinics and implement these protocols. Through this study, the well-being and functionality of frail elders and their caregivers could be improved. As falling has an enormous economic burden, a new effective fall prevention intervention could reduce health care costs substantially. The tests consisting of questionnaires and gait and balance measurement are non-invasive and safe. Taking blood samples is an invasive procedure, although no serious adverse effects are expected. There are no foreseeable risks associated with participation in this study. However, a burden will be placed on participating individuals because the training sessions and measurements are time-consuming.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one fall in the last 6 months
- •Living in their own home or in a home for the aged
- •Availability of a primary caregiver caring for the patient at least once a week
- •Ability to walk 15 meters independently (use of a walking aid is permitted)
- •Life expectancy of more than 6 months, as judged by their geriatrician
排除标准
- •Dyads of patients and caregivers in whom outcome assessment is highly unlikely to succeed, for example because they proved not to be able to register falls in the three months before randomization, will be excluded
- •MMSE score of less than 15
- •On the waiting list for a nursing home
研究组 & 干预措施
1
Intervention: 5 week training program, 2 sessions per week (total of 10 sessions). Training includes both the patient and the caregiver. The training consists of two components: a cognitive and a physical component.
干预措施: Fall prevention course (Behavioral)
2
Usual care.
结局指标
主要结局
Falls incidence rate
时间窗: 6 months
次要结局
- Burden for the caregiver(4 measurements within 6 months)
- Quality of life (MOS-20)(4 measurements within 6 months)
- Balance confidence(4 measurements within 6 months)
- Depression and general anxiety(4 measurements within 6 months)
- Functional performance and activities of daily living(4 measurements within 6 months)
- Mood(4 measurements within 6 months)
- Physical activity(4 measurements within 6 months)
- Mobility(4 measurements within 6 months)
- Balance(4 measurements within 6 months)
- Cognition(4 measurements within 6 months)
- Fear of falling (FES)(4 measurements within 6 months)
- Mental well being(4 measurements within 6 months)