Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People
2012年7月9日 更新者：Maastricht University Medical Center
Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community
The main objectives of this study are:
- an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail community-dwelling older people,
- a process evaluation of the feasibility of the program, with the following main outcomes: population reached, performance according to protocol, exposure and engagement, opinion on the program of participants and facilitators, perceived benefit or achievement, and experienced barriers and potential solutions, and
- an economical evaluation on the impact of the program on healthcare utilization and related costs.
研究概览
研究类型
介入性
注册 (实际的)
389
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
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Maastricht、荷兰、6221 GT
- Maastricht University
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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
70年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Aged 70 years or over
- At least some concerns about falling
- At least some associated avoidance of activity
- Fair or poor perceived general health
- Living independently in the community
- Written informed consent
Exclusion Criteria:
- Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
- Language or hearing problems that impede completing an interview by telephone
- Sight problems that impede completing the intervention
- Confinement to bed
- Waiting for nursing home admission
- Permanent use of a wheelchair
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：治疗
- 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：Cognitive behavioral program
an in-home cognitive behavioral program on managing concerns about falling and associated activity avoidance in frail community-dwelling older people facilitated by trained community nurses.
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The in-home cognitive behavioral program aims to learn older persons, living in the community, how to deal with concerns about falling and to increase physical, social and functional activity.
The principles of cognitive restructuring are used for shifting maladaptive in adaptive attitudes with respect to falling as well as increasing self efficacy beliefs and feelings of control.
The following themes are discussed during the program: concerns about falling, thoughts about falling, physical exercise, assert oneself, overcome personal barriers, recognizing fall-ty habits and managing concerns about falling.
Duration of the program is 10 weeks with 7 individual sessions (3 home visits (60, 60 and 75 minutes, respectively) & 4 telephone contacts (35 minutes each).
The program is facilitated by trained nurses qualified in the field of geriatrics and working for home care agencies.
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无干预：Control group
no program, only care as usual
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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concerns about falling
大体时间：baseline, 5 months and 12 months
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Falls Efficacy Scale International (FES-I)
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baseline, 5 months and 12 months
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avoidance of activities due concerns about falling
大体时间：baseline, 5 months and 12 months
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Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)
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baseline, 5 months and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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disability
大体时间：baseline, 5 months and 12 months
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Groningen Activity Restriction Scale (GARS)
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baseline, 5 months and 12 months
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number of falls
大体时间：continuous registration during the course of the trial for a period of 1 year
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Fall calendar
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continuous registration during the course of the trial for a period of 1 year
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catastrophic beliefs about falling
大体时间：baseline, 5 months and 12 months
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Catastrophic beliefs about falling (CAFS)
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baseline, 5 months and 12 months
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perceived consequences of falling
大体时间：baseline, 5 months and 12 months
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CoF - loss of functional independence subscale and damage to identity subscale
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baseline, 5 months and 12 months
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perceived control over falling
大体时间：baseline, 5 months and 12 months
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Perceived control over falling (PCOF)
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baseline, 5 months and 12 months
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mastery
大体时间：baseline, 5 months and 12 months
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Personal Mastery Scale
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baseline, 5 months and 12 months
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feelings of anxiety
大体时间：baseline, 5 months and 12 months
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Subscale of the Hospital Anxiety and Depression Scale (HADS-A)
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baseline, 5 months and 12 months
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symptoms of depression
大体时间：baseline, 5 months and 12 months
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Subscale of the Hospital Anxiety and Depression Scale (HADS-D)
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baseline, 5 months and 12 months
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social support interactions
大体时间：baseline, 5 months and 12 months
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Social support interactions (SSL 12-I)
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baseline, 5 months and 12 months
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health-related quality of life
大体时间：baseline, 5 months and 12 months
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SF-12 Health Survey
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baseline, 5 months and 12 months
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Dorresteijn TA, Rixt Zijlstra GA, Van Eijs YJ, Vlaeyen JW, Kempen GI. Older people's preferences regarding programme formats for managing concerns about falls. Age Ageing. 2012 Jul;41(4):474-81. doi: 10.1093/ageing/afs007. Epub 2012 Feb 23.
- Dorresteijn TA, Zijlstra GA, Delbaere K, van Rossum E, Vlaeyen JW, Kempen GI. Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032]. BMC Health Serv Res. 2011 Sep 20;11:228. doi: 10.1186/1472-6963-11-228.
- Evers SMAA, Dorresteijn TAC, Wijnen BFM, van Haastregt JCM, Kempen GIJM, Zijlstra GAR. Economic evaluation of a home-based programme to reduce concerns about falls in frail, independently-living older people. Expert Rev Pharmacoecon Outcomes Res. 2020 Dec;20(6):641-651. doi: 10.1080/14737167.2019.1666714. Epub 2019 Sep 20.
- Dorresteijn TA, Zijlstra GA, Ambergen AW, Delbaere K, Vlaeyen JW, Kempen GI. Effectiveness of a home-based cognitive behavioral program to manage concerns about falls in community-dwelling, frail older people: results of a randomized controlled trial. BMC Geriatr. 2016 Jan 6;16:2. doi: 10.1186/s12877-015-0177-y. Erratum In: BMC Geriatr. 2016;16:108.
- Dorresteijn TA, Rixt Zijlstra GA, Van Haastregt JC, Vlaeyen JW, Kempen GI. Feasibility of a nurse-led in-home cognitive behavioral program to manage concerns about falls in frail older people: a process evaluation. Res Nurs Health. 2013 Jun;36(3):257-70. doi: 10.1002/nur.21534. Epub 2013 Mar 26.
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
2009年3月1日
初级完成 (实际的)
2011年5月1日
研究完成 (实际的)
2011年5月1日
研究注册日期
首次提交
2011年5月17日
首先提交符合 QC 标准的
2011年5月19日
首次发布 (估计)
2011年5月23日
研究记录更新
最后更新发布 (估计)
2012年7月10日
上次提交的符合 QC 标准的更新
2012年7月9日
最后验证
2012年7月1日
更多信息
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.