Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial.
Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial.
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测量个性化音乐干预对痴呆症疗养院居民激越行为的影响：整群随机适应性试验的设计特点。
DOI：
10.1186/s13063-021-05620-y
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发表时间：
2021-10-07
期刊：
影响因子：
2.5
通讯作者：
Mor V
中科院分区：
文献类型：
--
作者：
McCreedy EM;Gutman R;Baier R;Rudolph JL;Thomas KS;Dvorchak F;Uth R;Ogarek J;Mor V
焦虑症和攻击性行为在养老院痴呆症患者中很常见。通常用于控制行为的药物有危险的副作用。NHS正在采用非药物干预措施来管理行为，尽管缺乏有效性证据和对最佳实施战略的了解。我们正在进行一项适应性试验，以评估个性化音乐对行为的影响。适应性试验可以通过在试验进行期间学习和修改试验来提高效率并降低与传统随机对照试验相关的成本。我们正在进行两个连续的平行整群随机试验，每个试验中有54个NHS(27个治疗组，27个对照组)。参与的NHS是从4家公司招募的，这些公司的规模、所有权结构、地理位置和居民的种族构成都不同。在随机化后，随机分配到每个试验的NHS之间在基线行为、符合条件的居民数量、认知障碍程度或抗精神病药物使用方面没有显著差异。通过工作人员面谈(主要结果)、护理人员进行住院医生评估(次要结果)和直接观察住院医生(次要结果)来评估激动行为的频率。在两个平行试验之间，适应性设计将用于测试替代实施战略，越来越多地招募可能从干预中受益的居民，并无缝地进行III/IV阶段试验。这项适应性试验使研究人员能够在实际的、真实的条件下评估流行的非药物干预(个性化音乐)对居民行为的影响，测试两种实施策略。这一设计有可能缩短研究时间线，方法是提高动力结果的可能性，更多地招募最有可能从干预中受益的居民，按顺序评估同一试验中实施策略的有效性，并创建统计模型以减少未来对现场数据收集的需求。该设计还可以通过招募和定制干预措施来增加研究的公平性，否则被排除在研究之外的人群。我们的设计将为其他干预措施的务实测试提供信息，这些干预措施的有效性证据有限，但由于现实世界对非药物方法的需求，利益相关者广泛采用。临床试验.政府NCT03821844.注册日期为2019年1月30日。这项试验登记符合世界卫生组织(WHO)的最低标准。网上版载有补充材料，可在10.1186/s13063-021-05620-y查阅。
Agitated and aggressive behaviors (behaviors) are common in nursing home (NH) residents with dementia. Medications commonly used to manage behaviors have dangerous side effects. NHs are adopting non-pharmacological interventions to manage behaviors, despite a lack of effectiveness evidence and an understanding of optimal implementation strategies. We are conducting an adaptive trial to evaluate the effects of personalized music on behaviors. Adaptive trials may increase efficiency and reduce costs associated with traditional RCTs by learning and making modifications to the trial while it is ongoing. We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control). Participating NHs were recruited from 4 corporations which differ in size, ownership structure, geography, and residents’ racial composition. After randomization, there were no significant differences between the NHs randomized to each trial with respect to baseline behaviors, number of eligible residents, degree of cognitive impairment, or antipsychotic use. Agitated behavior frequency is assessed via staff interviews (primary outcome), required nursing staff conducted resident assessments (secondary outcome), and direct observations of residents (secondary outcome). Between the two parallel trials, the adaptive design will be used to test alternative implementation strategies, increasingly enroll residents who are likely to benefit from the intervention, and seamlessly conduct a stage III/IV trial. This adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents’ behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also increase research equity by enrolling and tailoring the intervention to populations otherwise excluded from research. Our design will inform pragmatic testing of other interventions with limited efficacy evidence but widespread stakeholder adoption because of the real-world need for non-pharmaceutical approaches. ClinicalTrials.govNCT03821844. Registered on January 30, 2019. This trial registration meets the World Health Organization (WHO) minimum standard. The online version contains supplementary material available at 10.1186/s13063-021-05620-y.
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影响因子：
5.3
作者：
Cohen-Mansfield, Jiska;Thein, Khin;Freedman, Laurence
通讯作者：
Freedman, Laurence
影响因子：
5.7
作者：
Jolles, Monica Perez;Lengnick-Hall, Rebecca;Mittman, Brian S.
通讯作者：
Mittman, Brian S.
影响因子：
3
作者：
DeBois, Kristen A.;Evans, Shelly D.;Chatfield, Sheryl L.
通讯作者：
Chatfield, Sheryl L.
DOI：
10.1093/geronj/44.3.m77
发表时间：
1989-05-01
期刊：
JOURNALS OF GERONTOLOGY
影响因子：
--
作者：
COHENMANSFIELD, J;MARX, MS;ROSENTHAL, AS
通讯作者：
ROSENTHAL, AS
影响因子：
14.5
作者：
Jacobsen, Jorn-Henrik;Stelzer, Johannes;Turner, Robert
通讯作者：
Turner, Robert