Bordeaux Population Health Research Center, University Bordeaux, Inserm, ISPED, 146 rue Léo Saignat, CS61292, F-33076 BORDEAUX Cedex, UMR 1219, F-33000, Bordeaux, France.
Methodology Research Unit, Bordeaux University Hospital, Bordeaux, France.
BMC Geriatr. 2019 Feb 6;19(1):35. doi: 10.1186/s12877-019-1046-x.
There is a growing interest in developing tailored non-pharmacological strategies to face patients' needs in dementia. Occupational therapy (OT) may contribute to promote self-empowerment of both patients and caregivers. France has implemented nationwide OT over a short-term period of 3/4 months. The main objective of the MathéoAlz study is to measure the impact of maintaining OT over 4 supplementary months on patients' neuropsychiatric symptoms.
METHODS/DESIGN: The MatheoAlz trial (Maintenance of Occupational Therapy in Alzheimer's disease) is a multi-center, pragmatic randomized controlled trial testing maintenance of OT over 4 supplementary months compared to routine OT delivered as recommended. This paper describes the study protocol. MatheoAlz plans to enroll 240 dyads, i.e. dementia patients and caregivers, whose main inclusion criteria are: prescription for routine OT, patients with mild or moderate dementia, living at home, receiving support from an informal caregiver. The study will compare a control group of patients benefiting from 12 to 15 initial sessions of OT over 3/4 months and an intervention group of patients benefiting from these initial sessions plus 8 extra home sessions over 4 supplementary months. The main outcome is the patient's neuropsychiatric symptoms assessed by the Neuropsychiatric Inventory at 8 months. Several clinical outcomes and economic consequences are measured at 4, 8 and 12 months.
This is the first trial designed to assess the specific impact of the maintaining OT on the patients' neuropsychiatric symptoms burden. The results will inform policymakers on strategies to implement in the near future.
This trial was registered at ClinicalTrials.gov on February 16, 2018, identifier: NCT03435705 .
人们越来越感兴趣的是开发针对特定患者需求的非药物策略来应对痴呆症。职业疗法（OT）可以帮助增强患者和护理人员的自我能力。法国在短短 3/4 个月的时间内就在全国范围内实施了 OT。MathéoAlz 研究的主要目的是衡量在 4 个月的额外时间内维持 OT 对患者神经精神症状的影响。
方法/设计：MatheoAlz 试验（阿尔茨海默病职业疗法的维持）是一项多中心、实用的随机对照试验，旨在比较 4 个月的额外维持 OT 与按建议提供的常规 OT。本文描述了研究方案。MatheoAlz 计划招募 240 对患者和护理人员，其主要纳入标准为：常规 OT 的处方、轻度或中度痴呆的患者、居家生活、接受非正式护理人员的支持。研究将比较接受 3/4 个月 12-15 次初始 OT 治疗的对照组和接受这些初始治疗加 4 个月 8 次额外家庭治疗的干预组。主要结局是患者在 8 个月时通过神经精神疾病问卷评估的神经精神症状。在 4、8 和 12 个月时还测量了几个临床结局和经济后果。
这是首个旨在评估维持 OT 对患者神经精神症状负担的具体影响的试验。研究结果将为决策者提供有关在不久的将来实施哪些策略的信息。
该试验于 2018 年 2 月 16 日在 ClinicalTrials.gov 上注册，标识符：NCT03435705。
