Efficacy of Nonpharmacologic Interventions for Agitation in Advanced Dementia: A Randomized, Placebo-Controlled Trial

Efficacy of Nonpharmacologic Interventions for Agitation in Advanced Dementia: A Randomized, Placebo-Controlled Trial
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DOI:
10.4088/jcp.12m07918
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发表时间:
2012-09-01
影响因子:
5.3
通讯作者:
Freedman, Laurence
Freedman, Laurence
中科院分区:
医学2区
文献类型:
--
作者:
Cohen-Mansfield, Jiska;Thein, Khin;Freedman, Laurence

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背景资料:我们进行了一项随机、安慰剂对照的临床试验,以确定非药物个体化干预的疗效(个性化以解决未满足的需求,如无聊或疼痛)减少痴呆症患者的躁动。方法:焦虑的养老院老年痴呆患者(来自美国马里兰州5个地点的9家疗养院)被随机分为干预组(n = 89)和安慰剂对照组(n = 36)。在基线评估数据的基础上,对干预组使用了一种系统的方法,用于个体化非药物干预,探索躁动的治疗途径(TREA):假设未满足的需求,确定相应的治疗类别,并选择适合个人需求,过去的身份,偏好和能力的治疗细节。(未满足的需求是基于医生评估,结构化的工作人员访谈,相关问卷调查,用激越行为映射工具直接观察激越[主要结果测量]和Lawton改良行为流[次要结果测量]的影响,以及居民评估来假设的。实施TREA干预2周,记录躁动和情感观察结果。研究时间为2006年6月至2011年12月。结果:与对照组相比,针对未满足需求的TREA干预措施在统计学上显著降低了总需求。(P < .001),身体非攻击性(P < .001),言语激动(P = 0.004)和快乐的显着增加(P <0.001)和兴趣(P < .05)。这是第一个证明TREA疗效的大型随机对照试验,也是为数不多的非药物干预激越患者的试验之一。痴呆将这些发现转化为实践是迫切需要的,这将需要结构性的变化,专门的工作人员的时间来观察每一个激动的居民,确定未满足的需求,获得适当的干预材料,进行个性化的非药物干预,并评估结果。
Background: A randomized, placebo-controlled clinical trial was undertaken to determine the efficacy of nonpharmacologic individualized interventions (individualized to address unmet needs such as boredom or pain) in decreasing agitation in persons with dementia.Method: Agitated nursing home residents with advanced dementia (from 9 nursing homes in 5 locations in Maryland, United States) were randomized into an intervention group (n = 89) and a placebo control group (n = 36). On the basis of data from baseline assessment, a systematic methodology for individualizing nonpharmacologic interventions, Treatment Routes for Exploring Agitation (TREA), was used with the intervention group: an unmet need was hypothesized, a corresponding treatment category was identified, and specifics of the treatment were chosen to fit the person's need, past identity, preferences, and abilities. (Unmet needs were hypothesized based on physician evaluations, structured staff interviews, relative questionnaires, direct observations of agitation with the Agitation Behavior Mapping Instrument [the primary outcome measure] and affect with Lawton's Modified Behavior Stream [the secondary outcome measure], and resident assessments.) TREA interventions were implemented for 2 weeks, and observations of agitation and affect were recorded. The study was conducted from June 2006 until December 2011.Results: Relative to a control group, TREA interventions for unmet needs produced statistically significant declines in total (P < .001), physical nonaggressive (P < .001), and verbal agitation (P = .004) and significant increases in pleasure (P < .001) and interest (P < .05).Condusions:This is the first large randomized controlled trial to demonstrate the efficacy of TREA and one of only a few such trials of nonpharmacologic interventions for agitation in persons with dementia. The translation of these findings into practice is sorely needed and would require structural changes dedicating staff time to observing each agitated resident, determining unmet needs, obtaining appropriate intervention materials, conducting the individualized nonpharmacologic interventions, and evaluating results.