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一项针对痴呆症患者独立性的心理社会目标设定与手册化支持干预(NIDUS-家庭版)与目标设定及常规护理的单盲、3期、优效性随机对照试验。

A psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) versus goal setting and routine care: a single-masked, phase 3, superiority, randomised controlled trial.

作者信息

Cooper Claudia, Vickerstaff Victoria, Barber Julie, Phillips Rosemary, Ogden Margaret, Walters Kate, Lang Iain, Rapaport Penny, Orgeta Vasiliki, Rockwood Kenneth, Banks Sara, Palomo Marina, Butler Laurie T, Lord Kathyrn, Livingston Gill, Banerjee Sube, Manthorpe Jill, Dow Briony, Hoe Juanita, Hunter Rachael, Samus Quincy, Budgett Jessica

机构信息

Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University London, London, UK.

Research Department of Primary Care and Population Health, University College London, London, UK.

出版信息

Lancet Healthy Longev. 2024 Feb;5(2):e141-e151. doi: 10.1016/S2666-7568(23)00262-3.

DOI:10.1016/S2666-7568(23)00262-3
PMID:38310894
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC10834374/
Abstract

BACKGROUND

Although national guidelines recommend that everyone with dementia receives personalised post-diagnostic support, few do. Unlike previous interventions that improved personalised outcomes in people with dementia, the NIDUS-Family intervention is fully manualised and deliverable by trained and supervised, non-clinical facilitators. We aimed to investigate the effectiveness of home-based goal setting plus NIDUS-Family in supporting the attainment of personalised goals set by people with dementia and their carers.

METHODS

We did a two-arm, single-masked, multi-site, randomised, clinical trial recruiting patient-carer dyads from community settings. We randomly assigned dyads to either home-based goal setting plus NIDUS-Family or goal setting and routine care (control). Randomisation was blocked and stratified by site (2:1; intervention to control), with allocations assigned via a remote web-based system. NIDUS-Family is tailored to goals set by dyads by selecting modules involving behavioural interventions, carer support, psychoeducation, communication and coping skills, enablement, and environmental adaptations. The intervention involved six to eight video-call or telephone sessions (or in person when COVID-19-related restrictions allowed) over 6 months, then telephone follow-ups every 2-3 months for 6 months. The primary outcome was carer-rated goal attainment scaling (GAS) score at 12 months. Analyses were done by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN11425138.

FINDINGS

Between April 30, 2020, and May 9, 2021, we assessed 1083 potential dyads for eligibility, 781 (72·1%) of whom were excluded. Of 302 eligible dyads, we randomly assigned 98 (32·4%) to the control group and 204 (67·5%) to the intervention group. The mean age of participants with dementia was 79·9 years (SD 8·2), 169 (56%) were women, and 133 (44%) were men. 247 (82%) dyads completed the primary outcome, which favoured the intervention (mean GAS score at 12 months 58·7 [SD 13·0; n=163] vs 49·0 [14·1; n=84]; adjusted difference in means 10·23 [95% CI 5·75-14·71]; p<0·001). 31 (15·2%) participants in the intervention group and 14 (14·3%) in the control group experienced serious adverse events.

INTERPRETATION

To our knowledge, NIDUS-Family is the first readily scalable intervention for people with dementia and their family carers that improves attainment of personalised goals. We therefore recommend that it be implemented in health and care services.

FUNDING

UK Alzheimer's Society.

摘要

背景

尽管国家指南建议每位痴呆症患者都应获得个性化的诊断后支持,但很少有人能得到。与之前改善痴呆症患者个性化结局的干预措施不同,NIDUS - 家庭干预是完全手册化的,可由经过培训和监督的非临床协调员实施。我们旨在研究居家目标设定加NIDUS - 家庭干预在支持痴呆症患者及其护理人员实现个性化目标方面的有效性。

方法

我们进行了一项双臂、单盲、多中心、随机临床试验,从社区环境中招募患者 - 护理人员二元组。我们将二元组随机分配到居家目标设定加NIDUS - 家庭干预组或目标设定及常规护理组(对照组)。随机分组采用区组化并按地点分层(2∶1;干预组与对照组),通过基于网络的远程系统进行分配。NIDUS - 家庭干预通过选择涉及行为干预、护理人员支持、心理教育、沟通和应对技巧、赋能及环境适应的模块,来针对二元组设定的目标进行调整。干预包括在6个月内进行6至8次视频通话或电话会议(在与新冠疫情相关限制允许时可面对面进行),然后在接下来的6个月里每2 - 3个月进行一次电话随访。主要结局是12个月时护理人员评定的目标达成量表(GAS)得分。分析采用意向性分析。本试验已在国际标准随机对照试验编号注册库(ISRCTN)注册,注册号为ISRCTN11425138。

结果

在2020年4月30日至2021年5月9日期间,我们评估了1083个潜在二元组的资格,其中781个(72.1%)被排除。在302个符合条件的二元组中,我们将98个(32.4%)随机分配到对照组,204个(67.5%)随机分配到干预组。痴呆症患者参与者的平均年龄为79.9岁(标准差8.2),169名(56%)为女性,133名(44%)为男性。247个(82%)二元组完成了主要结局评估,结果有利于干预组(12个月时的平均GAS得分:干预组为58.7[标准差13.0;n = 163],对照组为49.0[14.1;n = 84];调整后的均值差异为10.23[95%置信区间5.75 - 14.71];p<0.001)。干预组有31名(15.2%)参与者和对照组有14名(14.3%)参与者经历了严重不良事件。

解读

据我们所知,NIDUS - 家庭干预是首个易于扩展应用于痴呆症患者及其家庭护理人员的干预措施,可提高个性化目标的达成率。因此,我们建议在卫生和护理服务中实施该干预措施。

资助

英国阿尔茨海默病协会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de0a/10834374/0ab8669d8fab/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de0a/10834374/3902b29740fc/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de0a/10834374/0ab8669d8fab/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de0a/10834374/3902b29740fc/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de0a/10834374/0ab8669d8fab/gr2.jpg

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