Nonpharmacologic Management of Challenging Behaviors in Veterans with Dementia

描述(由申请人提供)： 超过500万美国人患有阿尔茨海默病或相关痴呆症，这是一种进行性和不可逆转的神经退行性综合征，到2050年，患病率预计将达到近1600万人。在65岁及以上的退伍军人中，痴呆症的患病率与普通人群相似，除非裔美国人外，所有种族的痴呆症患病率均为7.3%，非裔美国人的痴呆症患病率比普通人群高50%。痴呆症的一个特征是神经精神症状(NPS；例如，激动、冷漠、攻击性)。NPS与医疗保健成本增加、生活质量和日常功能降低、家庭照顾者负担加重以及养老院安置有关。标准护理通常涉及药物，但这些充其量只能算是适度有效，存在包括死亡在内的严重风险，而且不能解决家庭自己认为最令人痛苦的行为症状，也不能促使他们安置养老院。这项研究解决了开发和测试创新的非药物方法来管理患有痴呆症的退伍军人的NPS的迫切需要。我们建议进行第三阶段疗效试验，以测试变革性的以患者为中心的干预措施，即定制活动计划(TAP)，该计划涉及系统评估，以确定退伍军人保留的能力和缺陷区域，以及以前可用于定制活动的角色、习惯和兴趣。在长达4个月的8次家庭会议中，主要家庭照顾者接受培训，将量身定做的活动纳入日常护理程序。TAP将以随机两组平行设计进行测试，其中160名患有痴呆症的种族和民族多样化的退伍军人及其主要家庭照顾者将被随机分配到TAP或关注对照组，并在基线、4个月和8个月进行访谈，以评估对NPS、照顾者福祉和成本的影响。我们的主要研究目的是关注患有痴呆症的退伍军人，并测试TAP在4个月后对NPS的即时效果。我们的假设是，与被分配到注意对照组的退伍军人相比，接受TAP治疗的痴呆症退伍军人在神经精神病学问卷(NPI)上的总分会更低，NPI评估12种常见神经精神症状的频率和严重程度。我们还提出了四个次要目标。1)测试8个月后服用TAP对退伍军人痴呆患者生活质量和神经精神行为的长期影响。假设：与注意控制组的退伍军人相比，接受TAP的退伍军人在一段时间内(基线为8个月)将表现出更高的生活质量和更低的NPI总分；2)测试TAP在4个月时的即时效果和8个月时的长期效果对照顾者负担、技能获得、使用活动的有效性和提供护理的时间。假设：接受TAP的照顾者在4个月和8个月时将报告与对照组相比，负担减轻，使用活动的技能和有效性增强，提供护理的时间更少；3)检查接受TAP的照顾者在8个月时是否正在使用活动；以及4)检查TAP是否导致患有痴呆症的退伍军人及其照顾者的VHA医疗使用和成本减少。这些次级目标的结果将提供进一步的有效性证据，确定是否有必要加强会议，并为技术援助方案的传播工作和全系统的翻译提供信息。我们的长期目标是，如果被证明有效，将TAP整合到VHA系统内的标准护理实践中，作为解决居家痴呆退伍军人NPS的首选治疗方案。这将改变目前依赖于药物管理的痴呆症护理模式。

DESCRIPTION (provided by applicant): Over 5 million Americans have Alzheimer's disease or related dementias, a progressive and irreversible neurodegenerative syndrome, with prevalence rates expected to reach close to 16 million individuals by 2050. Among Veterans 65 and older, prevalence rates are similar to the population at-large with 7.3% having dementia across all races, except for African-Americans for whom the rate is 50% higher. A hallmark of dementia is neuropsychiatric symptoms (NPS; e.g., agitation, apathy, aggressiveness). NPS are associated with increased health care costs, and reduced quality of life and daily functioning, heightened family caregiver burden, and nursing home placement. Standard care typically involves pharmacologic agents, but these are at best modestly effective, carry serious risks including mortality, and do not address behavioral symptoms families themselves consider most distressful or that prompt nursing home placement. This study addresses the urgent need to develop and test innovative nonpharmacologic approaches to manage NPS in Veterans with dementia. We propose a Phase III efficacy trial to test a transformative patient-centric intervention, the Tailored Activity Program (TAP) that involves a systematic assessment to identify Veterans' preserved capabilities and deficit areas, and previous roles, habits and interests from which to tailor activities. In up to 8 home sessions over 4 months, the primary family caregiver is trained to incorporate tailored activities into daily care routines. TAP will be tested in a randomized two-group parallel design in which 160 racially and ethnically diverse Veterans with dementia and their primary family caregivers will be randomly assigned to TAP or an attention control group and interviewed at baseline, 4 and 8 months to evaluate effect on NPS, caregiver well-being and costs. Our primary study aim concerns the Veteran with dementia and tests the immediate effect of TAP at 4-months on NPS. Our hypothesis is that Veterans with dementia who receive TAP will manifest lower total scores on the Neuropsychiatric Inventory (NPI), which assesses frequency and severity of 12 common neuropsychiatric symptoms, compared to Veterans assigned to an attention control group. We also propose four secondary aims. These are to: 1) Test the long-term effects of TAP at 8-months on quality of life and neuropsychiatric behaviors of Veterans with dementia. Hypothesis: Veterans receiving TAP will manifest higher quality of life and lower total NPI scores over time (baseline to 8- months) in comparison to Veterans in the attention control group; 2) Test the immediate effects of TAP at 4-months and long-term effects at 8-months on caregiver burden, skill acquisition, efficacy using activities, and time spent providing care. Hypotheses: Caregivers receiving TAP will report reduced burden, enhanced skills and efficacy using activities, and less time providing care compared to the control group at 4, and 8-months; 3) Examine whether caregivers receiving TAP are using activities at 8 months; and 4) Examine whether TAP results in reduced VHA health care use and costs for Veterans with dementia and their caregivers. Results from these secondary aims will provide further evidence of efficacy, identify whether booster sessions are necessary, and inform dissemination efforts and translation of TAP system-wide. Our long-term objective, if proven efficacious, is to integrate TAP into standard care practices within the VHA system as the first treatment choice to address NPS in Veterans with dementia living at home. This would transform the current paradigm of dementia care which relies on pharmacologic management.