Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial
Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial
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DOI：
10.1016/s0140-6736(16)30950-3
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发表时间：
2016-08-20
期刊：
影响因子：
168.9
通讯作者：
van Gool, Willem A.
中科院分区：
文献类型：
--
作者：
van Charante, Eric P. Moll;Richard, Edo;van Gool, Willem A.
背景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人群中的痴呆症。方法在这个开放标签，群集随机对照试验中，我们招募了70-78岁的个人，通过参与一般的做法在荷兰。通过计算机生成的随机序列，将每个医疗保健中心的一般做法随机分配（1：1）到6年护士领导的多领域心血管干预或对照（常规护理）。主要结局是随访6年时痴呆的累积发生率和残疾评分（学术医学中心线性残疾评分[ALDS]）。主要次要结局为心血管疾病事件和死亡率。结果评估者对分组设盲。分析包括所有具有可用结局数据的参与者。该试验在ISRCTN注册，编号ISRCTN 29711771。结果2006年6月7日至2009年3月12日，在26个卫生保健中心招募了116名全科医生（3526名参与者），并随机分配：63名（1890名参与者）被分配到干预组，53名（1636名参与者）被分配到对照组。获得了3454例（98%）参与者的主要结局数据;中位随访时间为6.7年（21341人-年）。干预组1853名参与者中有121名（7%）发生痴呆，对照组1601名参与者中有112名（7%）发生痴呆（风险比[HR] 0.92，95%CI 0.71-1.19; p=0.54）。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 [SD 6.8]，对照组为85.7 [7.1];校正后的平均差异为-0.02，95% CI为-0.38至0.42; p= 0.93）。干预组1885名参与者中有309名（16%）死亡，而对照组1634名参与者中有269名（16%）死亡（HR 0.98，95% CI 0.80-1.18; p=0.81）。两组之间的心血管疾病发病率没有差异（干预组1469名参与者中有273名[19%]，对照组1307名参与者中有228名[17%]; HR 1.06，95%CI 0.86-1.31; p=0.57）。解释护士主导的多领域干预并没有导致老年人中的老年人中全因痴呆症的发病率降低。这种缺乏效果可能是由适度的基线心血管风险和高标准的常规护理造成的。未来的研究应评估这些干预措施在选定人群中的有效性。
Background 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.Methods 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.Findings 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).Interpretation 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.