Comprehensive Intervention for Falls Prevention in the Elderly
研究概览
详细说明
Falls and related injuries among elderly people are a major public health problem worldwide.All older people with recurrent falls or assessed as being at increased risk of falling should be considered for an individualized multifactorial intervention.
In successful multifactorial intervention programmes the following specific components are common - against a background of the general diagnosis and management of causes and recognized risk factors:
- exercise
- home hazard assessment and intervention
- vision assessment and referral
- medications list review with modification/withdrawal We will address to 4000 randomly chosen patients from study population (elderly (65+) men and women, living in Beer-Sheva and Ofakim , Israel and belonging to Clalit HMO). This telephone interview will be conducted to reveal falls in last 12 months. The people who do fall (1 + falls) will be invited to research assistant.
In that meeting the research assistant will explain about the study aims and ask them to sign informed consent. Those who do not agree to participate - will be referred to their family doctor for further assessment.
Those who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU&G).
Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group. All participants will be instructed to call to the research assistant closely to each fall.
All information about assessment of patients in both groups will be transferred to the family physician. Their family physician according to his opinion will treat patients from usual care group.
A geriatrician, physiotherapist and occupational therapist will observe patients in the intervention group. OT will conduct a home visit to assess hazard and level of risk factor for falling. Results of assessment will be discussed on multi- disciplinary team meeting.
According to this plan each patient in this group will receive one or more following interventions:
- Written recommendation to the family physician for medication adjustment. As well, the geriatrician will discuss with family physician these recommendations.
- Recommendation to the family physician to refer the patient to optometrist/ ophthalmologist.
- Physical therapy: each subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations. All subjects will get brochure for home exercise. It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions.
- Occupational therapy: OT will make recommendation for changing any unsafe environments in the home.
First follow-up (four months after baseline assessment):
- OT will make a second home visit to each subject of the intervention group to check recommendation fulfillment.
- Study assistant will repeat baseline assessment (MMSE, GDS, BI, TU&G and visual assessment by Snellen chart).
- Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
- Information about medication adjustment and changes will be collected from Clalit computerized system.
Second follow-up (12 months after baseline assessment ) :
- Study assistant will repeat baseline assessment (MMSE, GDS, BI, TUG test and visual assessment by Snellen chart).
- Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
- Information about medication adjustment and changes will be collected from Clalit computerized system.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Beer- Sheva、以色列
- Department of Family Medicine, Faculty of Health Sciences, Ben Gurion University of the Negev
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Living in Beer Sheva or Ofakim , Israel
- Members of Clalit HMO
- 1 or more falls in past 12 month (self-reported)
- Age 65 or more
- Mobile outdoors without wheelchair
Exclusion Criteria:
- Seriously ill patients - as dyspnea with light exercise, unstable heart disease
- MMSE less than 18
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Intrevention group
each subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations.
All subjects will get brochure for home exercise.
It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions
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Comprehensive Multidisciplinary Intervention
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无干预:Control group
Those who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU&G). Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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number of falls
大体时间:4 and 12 monthes
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4 and 12 monthes
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- sor444506ctil
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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