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Comprehensive Intervention for Falls Prevention in the Elderly

2016年4月20日 更新者:Yan Press、Soroka University Medical Center
The purpose of this study is to determine whether the comprehensive multidisciplinary intervention (geriatrician, physical therapist and occupational therapist falls risk assessment and intervention)is effective in the falls prevention in the community dwelling 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:

  1. Written recommendation to the family physician for medication adjustment. As well, the geriatrician will discuss with family physician these recommendations.
  2. Recommendation to the family physician to refer the patient to optometrist/ ophthalmologist.
  3. 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.
  4. Occupational therapy: OT will make recommendation for changing any unsafe environments in the home.

First follow-up (four months after baseline assessment):

  1. OT will make a second home visit to each subject of the intervention group to check recommendation fulfillment.
  2. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TU&G and visual assessment by Snellen chart).
  3. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
  4. Information about medication adjustment and changes will be collected from Clalit computerized system.

Second follow-up (12 months after baseline assessment ) :

  1. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TUG test and visual assessment by Snellen chart).
  2. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
  3. Information about medication adjustment and changes will be collected from Clalit computerized system.

研究类型

介入性

注册 (实际的)

8

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Beer- Sheva、以色列
        • Department of Family Medicine, Faculty of Health Sciences, Ben Gurion University of the Negev

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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
Comprehensive Multidisciplinary Intervention
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
number of falls
大体时间:4 and 12 monthes
4 and 12 monthes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2011年6月1日

研究完成 (实际的)

2011年6月1日

研究注册日期

首次提交

2006年12月19日

首先提交符合 QC 标准的

2006年12月19日

首次发布 (估计)

2006年12月20日

研究记录更新

最后更新发布 (估计)

2016年4月21日

上次提交的符合 QC 标准的更新

2016年4月20日

最后验证

2006年12月1日

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.

Comprehensive Multidisciplinary Intervention的临床试验

3
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