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辅助技术和远程监护以维持痴呆症患者的独立居家生活:ATTILA RCT 研究。

Assistive technology and telecare to maintain independent living at home for people with dementia: the ATTILA RCT.

机构信息

Department of Old Age Psychiatry, King's College London, London, UK.

Medical Research Council Population Health Research Unit, University of Oxford, Oxford, UK.

出版信息

Health Technol Assess. 2021 Mar;25(19):1-156. doi: 10.3310/hta25190.

Abstract

BACKGROUND

Assistive technology and telecare have been promoted to manage the risks associated with independent living for people with dementia, but there is limited evidence of their effectiveness.

OBJECTIVES

This trial aimed to establish whether or not assistive technology and telecare assessments and interventions extend the time that people with dementia can continue to live independently at home and whether or not they are cost-effective. Caregiver burden, the quality of life of caregivers and of people with dementia and whether or not assistive technology and telecare reduce safety risks were also investigated.

DESIGN

This was a pragmatic, randomised controlled trial. Blinding was not undertaken as it was not feasible to do so. All consenting participants were included in an intention-to-treat analysis.

SETTING

This trial was set in 12 councils in England with adult social services responsibilities.

PARTICIPANTS

Participants were people with dementia living in the community who had an identified need that might benefit from assistive technology and telecare.

INTERVENTIONS

Participants were randomly assigned to receive either assistive technology and telecare recommended by a health or social care professional to meet their assessed needs (a full assistive technology and telecare package) or a pendant alarm, non-monitored smoke and carbon monoxide detectors and a key safe (a basic assistive technology and telecare package).

MAIN OUTCOME MEASURES

The primary outcomes were time to admission to care and cost-effectiveness. Secondary outcomes assessed caregivers using the 10-item Center for Epidemiological Studies Depression Scale, the State-Trait Anxiety Inventory 6-item scale and the Zarit Burden Interview.

RESULTS

Of 495 participants, 248 were randomised to receive full assistive technology and telecare and 247 received the limited control. Comparing the assistive technology and telecare group with the control group, the hazard ratio for institutionalisation was 0.76 (95% confidence interval 0.58 to 1.01;  = 0.054). After adjusting for an imbalance in the baseline activities of daily living score between trial arms, the hazard ratio was 0.84 (95% confidence interval 0.63 to 1.12;  = 0.20). At 104 weeks, there were no significant differences between groups in health and social care resource use costs (intervention group - control group difference: mean -£909, 95% confidence interval -£5336 to £3345) or in societal costs (intervention group - control group difference: mean -£3545; 95% confidence interval -£13,914 to £6581). At 104 weeks, based on quality-adjusted life-years derived from the participant-rated EuroQol-5 Dimensions questionnaire, the intervention group had 0.105 (95% confidence interval -0.204 to -0.007) fewer quality-adjusted life-years than the control group. The number of quality-adjusted life-years derived from the proxy-rated EuroQol-5 Dimensions questionnaire did not differ between groups. Caregiver outcomes did not differ between groups over 24 weeks.

LIMITATIONS

Compliance with the assigned trial arm was variable, as was the quality of assistive technology and telecare needs assessments. Attrition from assessments led to data loss additional to that attributable to care home admission and censoring events.

CONCLUSIONS

A full package of assistive technology and telecare did not increase the length of time that participants with dementia remained in the community, and nor did it decrease caregiver burden, depression or anxiety, relative to a basic package of assistive technology and telecare. Use of the full assistive technology and telecare package did not increase participants' health and social care or societal costs. Quality-adjusted life-years based on participants' EuroQol-5 Dimensions questionnaire responses were reduced in the intervention group compared with the control group; groups did not differ in the number of quality-adjusted life-years based on the proxy-rated EuroQol-5 Dimensions questionnaire.

FUTURE WORK

Future work could examine whether or not improved assessment that is more personalised to an individual is beneficial.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN86537017.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 19. See the NIHR Journals Library website for further project information.

摘要

背景

辅助技术和远程监护已被推广用于管理痴呆症患者独立生活相关的风险,但它们的有效性证据有限。

目的

本试验旨在确定辅助技术和远程监护评估和干预是否可以延长痴呆症患者继续独立居家生活的时间,以及它们是否具有成本效益。还调查了照顾者负担、照顾者和痴呆症患者的生活质量,以及辅助技术和远程监护是否可以降低安全风险。

设计

这是一项实用的随机对照试验。由于无法进行盲法,因此未进行盲法。所有同意参与的参与者都将进行意向治疗分析。

设置

该试验在英格兰的 12 个具有成人社会服务职责的理事会进行。

参与者

参与者是居住在社区的患有痴呆症的人,他们有明确的需求,可能受益于辅助技术和远程监护。

干预措施

参与者被随机分配接受健康或社会护理专业人员推荐的辅助技术和远程监护以满足其评估需求(完整的辅助技术和远程监护包)或吊坠警报器、非监测烟雾和一氧化碳探测器和钥匙保险箱(基本的辅助技术和远程监护包)。

主要观察指标

主要结局是入住护理机构的时间和成本效益。次要结局评估了使用 10 项流行病学研究抑郁量表、状态特质焦虑量表 6 项量表和 Zarit 负担访谈的照顾者。

结果

在 495 名参与者中,248 名被随机分配接受完整的辅助技术和远程监护,247 名接受有限的对照。将辅助技术和远程监护组与对照组进行比较,机构化的风险比为 0.76(95%置信区间 0.58 至 1.01;= 0.054)。在调整试验臂之间基线日常生活活动评分的不平衡后,风险比为 0.84(95%置信区间 0.63 至 1.12;= 0.20)。在 104 周时,两组在健康和社会保健资源使用成本(干预组-对照组差异:均值-£909,95%置信区间-£5336 至 £3345)或社会成本(干预组-对照组差异:均值-£3545;95%置信区间-£13,914 至 £6581)方面没有显著差异。在 104 周时,基于参与者评定的 EuroQol-5 维度问卷的质量调整生命年,干预组的质量调整生命年比对照组少 0.105(95%置信区间-0.204 至-0.007)。基于代理评定的 EuroQol-5 维度问卷的质量调整生命年在两组之间没有差异。在 24 周内,照顾者结局在两组之间没有差异。

局限性

对指定试验臂的依从性是可变的,辅助技术和远程监护需求评估的质量也是可变的。从评估中流失的数据除了归因于入住疗养院和删失事件之外,还额外流失了数据。

结论

完整的辅助技术和远程监护套餐并未延长痴呆症患者在社区中的时间,也没有降低照顾者负担、抑郁或焦虑,与基本的辅助技术和远程监护套餐相比。使用完整的辅助技术和远程监护套餐并未增加参与者的健康和社会保健或社会成本。基于参与者 EuroQol-5 维度问卷回答的质量调整生命年在干预组中比对照组减少;两组在基于代理评定的 EuroQol-5 维度问卷的质量调整生命年方面没有差异。

未来工作

未来的工作可以研究是否改进更个性化的评估是否有益。

试验注册

当前对照试验 ISRCTN86537017。

资金

该项目由英国国家卫生研究所(NIHR)健康技术评估计划资助,将在 ; Vol. 25, No. 19 中全文发表。请访问 NIHR 期刊库网站以获取进一步的项目信息。

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