Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial
Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial
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DOI：
10.1136/bmjopen-2018-023436
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发表时间：
2019-06-01
期刊：
影响因子：
2.9
通讯作者：
Geretsegger, Monika
中科院分区：
文献类型：
--
作者：
Gold, Christian;Eickholt, Jasmin;Geretsegger, Monika
在老年人中，痴呆症和抑郁症与个人痛苦和高社会成本有关。音乐干预，如团体音乐治疗（GMT）和娱乐合唱团唱歌（RCS）已显示出有希望的效果，但其在临床亚组的比较有效性尚不清楚。本试验旨在确定GMT，RCS及其组合的有效性，为护理院居民，并检查异质性的治疗效果在subgroup.Methods和分析这一大型，务实，多国群集随机对照试验与2x2析因设计将比较GMT，RCS的影响，两者或两者都没有，为65岁或以上的老年痴呆症和抑郁症状的护理院居民。我们将在8个国家随机抽取100个护理之家单位，共计>= 1000名居民。每次干预将提供6个月（3个月2次/周，随后3个月1次/周），如果当地可用，允许延长。主要结局是6个月时蒙哥马利-阿斯伯格抑郁评定量表评分的变化。次要结局将包括抑郁症状、认知功能、神经精神症状、精神药物使用、照顾者负担、生活质量、死亡率和至少12个月的费用。该研究有90%的把握度来检测主效应，也有把握度来确定性别、严重程度和社会经济地位的相互作用效应。伦理和传播伦理批准已在一个国家获得，并将在所有国家获得。研究结果将在国家和国际会议上发表，并在科学期刊上发表。
Introduction In older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups.Methods and analysis This large, pragmatic, multinational cluster-randomised controlled trial with a 2x2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with >= 1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Asberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status.Ethics and dissemination Ethical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals.