Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Schwabachanlage 6, 91054, Erlangen, Germany.
Institute of Medical Informatics, Biometry, and Epidemiology (IMBE), Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Waldstraße 6, 91054, Erlangen, Germany.
BMC Geriatr. 2022 Dec 28;22(1):1001. doi: 10.1186/s12877-022-03695-z.
Severe dementia is one of the most challenging conditions when caring for people in nursing homes. A manualised non-pharmacological, psychosocial group intervention especially adapted to the needs of people with severe dementia (PWSDs) is currently still lacking. To close this gap, we adapted the evidence-based multicomponent non-pharmacological MAKS intervention (Motor stimulation, ADL stimulation, Cognitive [german: Kognitive] stimulation, and Social functioning in a group setting) to the special needs of PWSDs called the MAKS-s intervention, where the s stands for severe dementia.
In a prospective, multicentre, cluster-randomised trial with a waitlist control group design, 26 nursing homes comprising 152 PWSDs were randomly assigned to either the MAKS-s intervention group (IG) or control group (CG) - 121 PWSDs were still alive after the 6-month intervention period (t6) and included in the intention-to-treat (ITT) sample. The two primary outcomes, behavioural and psychological symptoms (BPSDs, measured with NPI-NH) and quality of life (QoL, measured with QUALIDEM), and the secondary outcome, activities of daily living (ADLs, measured with ADCS-ADL-sev), were assessed at baseline (t0) and at t6. Mixed ANOVAs were computed to investigate possible effects of the MAKS-s intervention on the outcomes.
In the ITT sample, BPSDs and QoL did not change significantly over time, and group assignment did not affect them, although the IG participants had significantly better overall QoL than the CG participants. ADLs decreased significantly over time, but group assignment did not affect them. Analyses in the per protocol (PP) sample showed comparable results, with the exception that the IG participants showed a significantly greater increase in BPSDs than the CG participants did.
Under the situational conditions of the Covid-19 pandemic, no beneficial effects of the MAKS-s intervention on BPSDs, QoL, or ADLs were observed. This finding also means that under 'normal circumstances' (i.e., if there had been no pandemic), we could not make any statements about the effect or non-effect of MAKS-s. In order to be able to address the hypotheses formulated here, the study will have to be repeated incorporating helpful experiences of the present study.
https://doi.org/10.1186/ISRCTN15722923 (Registered prospectively, 07. August 2019).
在养老院护理人员中，严重痴呆是最具挑战性的情况之一。目前仍然缺乏一种专门针对严重痴呆患者（PWSD）需求的、经过验证的非药物、心理社会群体干预措施。为了弥补这一空白，我们对基于证据的多成分非药物性 MAKS 干预措施（运动刺激、日常生活活动刺激、认知刺激和小组社交功能）进行了调整，使其适应 PWSD 的特殊需求，称为 MAKS-s 干预措施，其中 s 代表严重痴呆。
采用前瞻性、多中心、集群随机试验和等待对照设计，将 26 家养老院的 152 名 PWSD 随机分为 MAKS-s 干预组（IG）或对照组（CG）-121 名 PWSD 在 6 个月的干预期（t6）后仍然存活并纳入意向治疗（ITT）样本。主要结局是行为和心理症状（NPI-NH 评估的 BPSD）和生活质量（QUALIDEM 评估的 QoL），次要结局是日常生活活动（ADCS-ADL-sev 评估的 ADL）。在基线（t0）和 t6 时评估。混合方差分析用于研究 MAKS-s 干预对结果的可能影响。
在 ITT 样本中，BPSD 和 QoL 随时间没有显著变化，组分配也没有影响它们，尽管 IG 参与者的整体 QoL 明显优于 CG 参与者。ADL 随时间显著下降，但组分配对其没有影响。PP 样本的分析结果类似，除了 IG 参与者的 BPSD 增加明显大于 CG 参与者外。
在新冠疫情的情况下，MAKS-s 干预措施对 BPSD、QoL 或 ADL 没有观察到有益的效果。这一发现还意味着，在“正常情况下”（即如果没有大流行），我们无法对 MAKS-s 的效果或非效果做出任何陈述。为了能够验证这里提出的假设，研究将不得不重复进行，并纳入本研究的有益经验。
https://doi.org/10.1186/ISRCTN15722923（于 2019 年 8 月 7 日前瞻性注册）。
