Department of General Practice, Academic Medical Centre, Amsterdam, Netherlands.
Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands; Department of Neurology, Radboud University Medical Centre, Nijmegen, Netherlands.
Lancet. 2016 Aug 20;388(10046):797-805. doi: 10.1016/S0140-6736(16)30950-3. Epub 2016 Jul 26.
Cardiovascular risk factors are associated with an increased risk of dementia. We assessed whether a multidomain intervention targeting these factors can prevent dementia in a population of community-dwelling older people.
In this open-label, cluster-randomised controlled trial, we recruited individuals aged 70-78 years through participating general practices in the Netherlands. General practices within each health-care centre were randomly assigned (1:1), via a computer-generated randomisation sequence, to either a 6-year nurse-led, multidomain cardiovascular intervention or control (usual care). The primary outcomes were cumulative incidence of dementia and disability score (Academic Medical Center Linear Disability Score [ALDS]) at 6 years of follow-up. The main secondary outcomes were incident cardiovascular disease and mortality. Outcome assessors were masked to group assignment. Analyses included all participants with available outcome data. This trial is registered with ISRCTN, number ISRCTN29711771.
Between June 7, 2006, and March 12, 2009, 116 general practices (3526 participants) within 26 health-care centres were recruited and randomly assigned: 63 (1890 participants) were assigned to the intervention group and 53 (1636 participants) to the control group. Primary outcome data were obtained for 3454 (98%) participants; median follow-up was 6·7 years (21 341 person-years). Dementia developed in 121 (7%) of 1853 participants in the intervention group and in 112 (7%) of 1601 participants in the control group (hazard ratio [HR] 0·92, 95% CI 0·71-1·19; p=0·54). Mean ALDS scores measured during follow-up did not differ between groups (85·7 [SD 6·8] in the intervention group and 85·7 [7·1] in the control group; adjusted mean difference -0·02, 95% CI -0·38 to 0·42; p=0·93). 309 (16%) of 1885 participants died in the intervention group, compared with 269 (16%) of 1634 participants in the control group (HR 0·98, 95% CI 0·80-1·18; p=0·81). Incident cardiovascular disease did not differ between groups (273 [19%] of 1469 participants in the intervention group and 228 [17%] of 1307 participants in the control group; HR 1·06, 95% CI 0·86-1·31; p=0·57).
A nurse-led, multidomain intervention did not result in a reduced incidence of all-cause dementia in an unselected population of older people. This absence of effect might have been caused by modest baseline cardiovascular risks and high standards of usual care. Future studies should assess the efficacy of such interventions in selected populations.
Dutch Ministry of Health, Welfare and Sport; Dutch Innovation Fund of Collaborative Health Insurances; and Netherlands Organisation for Health Research and Development.
心血管危险因素与痴呆风险增加相关。我们评估了针对这些因素的多领域干预是否可以预防社区居住的老年人发生痴呆。
在这项开放标签、整群随机对照试验中，我们通过荷兰的参与实践招募了 70-78 岁的个体。每个医疗中心内的实践通过计算机生成的随机序列，以 1:1 的比例随机分配到 6 年的护士主导的多领域心血管干预或对照组（常规护理）。主要结局是在 6 年随访时累积痴呆和残疾评分（学术医学中心线性残疾评分[ALDS]）的发生率。主要次要结局是心血管疾病的发生率和死亡率。结果评估者对组分配进行了盲法。分析包括所有具有可用结局数据的参与者。这项试验在 ISRCTN 注册，编号为 ISRCTN29711771。
2006 年 6 月 7 日至 2009 年 3 月 12 日，26 个医疗中心内的 116 个实践（3526 名参与者）被招募并随机分配：63 个（1890 名参与者）被分配到干预组，53 个（1636 名参与者）被分配到对照组。主要结局数据来自 3454 名（98%）参与者；中位随访时间为 6.7 年（21 341 人年）。在干预组的 1853 名参与者中，121 名（7%）发生痴呆，在对照组的 1601 名参与者中，112 名（7%）发生痴呆（风险比[HR]0.92，95%CI0.71-1.19；p=0.54）。在随访期间测量的平均 ALDS 评分在两组之间没有差异（干预组为 85.7[SD6.8]，对照组为 85.7[7.1]；调整后的平均差异-0.02，95%CI-0.38 至 0.42；p=0.93）。在干预组中，309 名（16%）参与者死亡，而在对照组中，269 名（16%）参与者死亡（HR0.98，95%CI0.80-1.18；p=0.81）。心血管疾病的发生率在两组之间没有差异（干预组的 1469 名参与者中有 273 名[19%]，对照组的 1307 名参与者中有 228 名[17%]；HR1.06，95%CI0.86-1.31；p=0.57）。
在未选择的老年人群中，护士主导的多领域干预并不能降低全因痴呆的发生率。这种无效应可能是由于基线心血管风险较低和常规护理标准较高所致。未来的研究应评估此类干预措施在选定人群中的疗效。
荷兰卫生部、福利和体育部；荷兰创新基金合作健康保险；荷兰健康研究和发展组织。
