The Memory Disorders Research Group, Department of Neurology, Rigshospitalet, Copenhagen University Hospital, 9 Blegdamsvej, 2100 Copenhagen, Denmark.
BMJ. 2012 Jul 17;345:e4693. doi: 10.1136/bmj.e4693.
To assess the efficacy at 12 months of an early psychosocial counselling and support programme for outpatients with mild Alzheimer's disease and their primary care givers.
Multicentre, randomised, controlled, rater blinded trial.
Primary care and memory clinics in five Danish districts.
330 outpatients with mild Alzheimer's disease and their 330 primary care givers.
Participating dyads (patient and primary care giver) were randomised to control support during follow-up or to control support plus DAISY intervention (multifaceted and semi-tailored counselling, education, and support).
Primary outcomes at 12 months for patients were change from baseline in mini mental state examination (MMSE) score, Cornell depression scale score, and proxy rated European quality of life visual analogue scale (EQ-VAS) score. For care givers, outcomes were change from baseline in geriatric depression scale (GDS 30 items) score and EQ-VAS score.
Because of multiple testing, statistical significance was set at an adjusted P limit of <0.0005. At 12 months there were no significant differences between the two allocation groups in changes from baseline in the primary and secondary outcomes. However, although non-significant with the adjusted P limit, a small difference was observed for one of the primary patient outcomes (Cornell depression scale score) in patients in favour of the DAISY intervention group before and after adjusting for attrition (P = 0.0146 and P = 0.0103 respectively).
The multifaceted, semi-tailored intervention with counselling, education, and support for patients with mild Alzheimer's disease and their care givers did not have any significant effect beyond that with well structured follow-up support at 12 months after adjustment for multiple comparisons. The small positive effect found in the unadjusted primary outcome addressing depressive symptoms in patients may call for further research focusing on patients with Alzheimer's disease and comorbid depression.
ISRCTN74848736.
评估早期心理社会咨询和支持计划对轻度阿尔茨海默病患者及其初级保健照顾者的 12 个月疗效。
多中心、随机、对照、盲法评估试验。
丹麦五个地区的初级保健和记忆诊所。
330 名轻度阿尔茨海默病患者及其 330 名初级保健照顾者。
参与的患者和照顾者（患者和初级保健照顾者）被随机分配到对照组（随访期间给予常规支持）或对照组加 DAISY 干预组（多方面、半定制的咨询、教育和支持）。
患者的主要观察指标为从基线开始的简易精神状态检查（MMSE）评分、康奈尔抑郁量表评分和代理评定的欧洲生活质量视觉模拟量表（EQ-VAS）评分的变化。照顾者的主要观察指标为从基线开始的老年抑郁量表（GDS 30 项）评分和 EQ-VAS 评分的变化。
由于多次测试，统计学意义设定为调整 P 值<0.0005。在 12 个月时，两组之间从基线开始的主要和次要结果的变化没有显著差异。然而，尽管调整后的 P 值没有显著差异，但在调整失访后，观察到一个主要患者结果（康奈尔抑郁量表评分）存在较小差异，有利于 DAISY 干预组（分别为 P = 0.0146 和 P = 0.0103）。
对于轻度阿尔茨海默病患者及其照顾者，采用咨询、教育和支持相结合的多方面、半定制干预措施，与 12 个月后的结构化随访支持相比，没有任何显著效果。在调整了多项比较后，患者的主要结局中发现的较小的积极影响可能需要进一步研究关注患有阿尔茨海默病和共病抑郁的患者。
ISRCTN74848736。
