Remote, lower-intensity, multidomain lifestyle intervention for subjective cognitive decline or mild cognitive impairment (APPLE-Tree): a multicentre, single-masked, randomised controlled trial.

IF 14.6 Q1 GERIATRICS & GERONTOLOGY
Harriet Demnitz-King, Mariam Adeleke, Julie A Barber, Michaela Poppe, Jessica Budgett, Sweedal Alberts, Larisa Duffy, Anne-Marie Minihane, Rachel Gillings, Hannah Chapman, Rosario Isabel Espinoza Jeraldo, Oliver Kelsey, Malvika Muralidhar, Sedigheh Zabihi, Elisa Aguirre, Nicholas Bass, Anna Betz, Henry Brodaty, Alexandra Burton, Paul Higgs, Rachael Maree Hunter, Jonathan Huntley, Helen C Kales, Iain Lang, Natalie L Marchant, Sarah Morgan-Trimmer, Penny Rapaport, Miguel Rio, Irene Petersen, Zuzana Walker, Kate Walters, Sube Banerjee, Joanne Rodda, Marina Palomo, Claudia Cooper
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引用次数: 0

Abstract

Background: Trials of high-intensity, multidomain interventions show that modifying lifestyle and psychological risk factors can slow cognitive decline. We aimed to evaluate the effectiveness of a lower-intensity, personally-tailored dementia prevention programme in improving cognition in adults with subjective cognitive decline or mild cognitive impairment.

Methods: We conducted a single-masked, multisite, randomised controlled clinical trial recruiting older adults with subjective cognitive decline or mild cognitive impairment across 11 sites in England. Participants were randomly assigned (1:1) to the 12-month Active Prevention in People at Risk of Dementia through Lifestyle, Behaviour Change and Technology to build Resilience (APPLE-Tree) intervention or to the control condition (usual care plus brief written information about dementia prevention). Randomisation was blocked and stratified by site, with allocations assigned via a remote web-based system. The intervention promoted healthy lifestyles, social connections, enjoyable activities, and self-management of long-term conditions. It comprised ten 1-h group video-call sessions over 6 months, supplemented with alternating, informal, 40-min video-call sessions (termed tea breaks) and individual goal-setting calls between sessions. From months 6 to 12, participants continued with monthly online tea breaks. The primary outcome was cognition (Neuropsychological Test Battery [NTB] score) at 24 months, analysed using an intention-to-treat approach. This trial was pre-registered with the ISRCTN Registry (ISRCTN17325135); further analyses are ongoing.

Findings: Between Oct 5, 2020, and Dec 31, 2022, we screened 1287 individuals for eligibility and randomly assigned 746 to the APPLE-Tree intervention (n=374) or control treatment (n=372). There were 177 (47%) women and 194 (52%) men in the intervention group and 173 (47%) women and 198 (53%) men in the control group. The primary outcome analysis included 635 (85%) of 746 participants. Mean NTB scores increased in both groups over time, with greater improvement in the intervention group than in the control group (mean 24-month NTB 0·33 [SD 0·67] vs 0·21 [0·75]; adjusted mean difference 0·06 [95% CI -0·001 to 0·128]; p=0·055). Serious adverse events occurred in 35 (9%) participants in the intervention group and 30 (8%) participants in the control group; none were intervention-related.

Interpretation: APPLE-Tree is an accessible intervention associated with small improvements in cognition, although these results were not statistically significant. Low-intensity interventions that can be delivered remotely by non-clinical facilitators have the potential for wide-scale implementation to support adults with memory concerns. However, further work is needed to optimise the intervention for delivery in routine settings.

Funding: Economic and Social Research Council and National Institute for Health and Care Research programme grant.

远程、低强度、多领域生活方式干预对主观认知能力下降或轻度认知障碍(APPLE-Tree):一项多中心、单盲、随机对照试验。
背景:高强度、多领域干预的试验表明,改变生活方式和心理风险因素可以减缓认知能力下降。我们的目的是评估低强度、个性化的痴呆预防方案在改善主观认知能力下降或轻度认知障碍的成人认知方面的有效性。方法:我们在英国的11个地点进行了一项单蒙面、多地点、随机对照临床试验,招募有主观认知能力下降或轻度认知障碍的老年人。参与者被随机(1:1)分配到12个月的通过生活方式、行为改变和技术建立恢复力的痴呆症风险人群积极预防(苹果树)干预或控制条件(常规护理加关于痴呆症预防的简短书面信息)。随机化被阻止并按地点分层,通过远程网络系统分配分配。干预措施促进了健康的生活方式、社会联系、愉快的活动和对长期状况的自我管理。它包括在6个月内进行10次1小时的小组视频通话,辅以交替进行的40分钟非正式视频通话(称为茶点休息)和会议之间的个人目标设定电话。从第6个月到第12个月,参与者继续每月在网上喝茶。主要结果是24个月时的认知(神经心理测试电池[NTB]评分),使用意向治疗方法进行分析。该试验已在ISRCTN注册中心预注册(ISRCTN17325135);进一步的分析正在进行中。研究结果:在2020年10月5日至2022年12月31日期间,我们筛选了1287名符合条件的个体,并将746名随机分配到苹果树干预组(n=374)或对照治疗组(n=372)。干预组女性177例(47%),男性194例(52%);对照组女性173例(47%),男性198例(53%)。主要结局分析包括746名参与者中的635名(85%)。两组平均NTB评分均随时间增加,干预组比对照组改善更大(24个月平均NTB 0.33 [SD 0.67] vs 0.21[0.75];调整后平均差异0.06 [95% CI - 0.001 ~ 0.128]; p= 0.055)。干预组35例(9%)、对照组30例(8%)发生严重不良事件;没有一个是干预相关的。解释:APPLE-Tree是一种可获得的干预措施,与认知能力的小幅改善有关,尽管这些结果没有统计学意义。可以由非临床辅助人员远程提供的低强度干预有可能大规模实施,以支持有记忆问题的成年人。然而,需要进一步的工作来优化在常规环境中实施的干预措施。资助:经济和社会研究理事会和国家卫生和保健研究所方案赠款。
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来源期刊
Lancet Healthy Longevity
Lancet Healthy Longevity GERIATRICS & GERONTOLOGY-
CiteScore
16.30
自引率
2.30%
发文量
192
审稿时长
12 weeks
期刊介绍: The Lancet Healthy Longevity, a gold open-access journal, focuses on clinically-relevant longevity and healthy aging research. It covers early-stage clinical research on aging mechanisms, epidemiological studies, and societal research on changing populations. The journal includes clinical trials across disciplines, particularly in gerontology and age-specific clinical guidelines. In line with the Lancet family tradition, it advocates for the rights of all to healthy lives, emphasizing original research likely to impact clinical practice or thinking. Clinical and policy reviews also contribute to shaping the discourse in this rapidly growing discipline.
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