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REMCARE:针对痴呆症患者及其家庭照顾者的回忆小组实用多中心随机试验:有效性与经济分析。

REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis.

作者信息

Woods Robert T, Orrell Martin, Bruce Errollyn, Edwards Rhiannon T, Hoare Zoe, Hounsome Barry, Keady John, Moniz-Cook Esme, Orgeta Vasiliki, Rees Janice, Russell Ian

机构信息

Dementia Services Development Centre Wales, Bangor University, Bangor, Gwynedd, United Kingdom.

Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.

出版信息

PLoS One. 2016 Apr 19;11(4):e0152843. doi: 10.1371/journal.pone.0152843. eCollection 2016.

Abstract

BACKGROUND

Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.

METHODS

This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point), usually in the person's home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV), who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5)were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control). The intervention evaluated was joint reminiscence groups (with up to 12 dyads) weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD), psychological distress for the carer (General Health Questionnaire, GHQ-28). Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both.

RESULTS

The intention to treat analysis (ANCOVA) identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes (self-reported QoL-AD mean difference 0.07 (-1.21 to 1.35), F = 0.48, p = 0.53). Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a General Health Questionnaire-28 sub-scale at the ten month end-point (mean difference 1.25 (0.25 to 2.26), F = 8.28, p = 0.04). Compliance analyses suggested improved autobiographical memory, quality of life and relationship quality for people with dementia attending more reminiscence sessions, however carers attending more groups showed increased care-giving stress. Economic analyses from a public sector perspective indicated that joint reminiscence groups are unlikely to be cost-effective. There were no significant adverse effects attributed to the intervention. Potential limitations of the study include less than optimal attendance at the group sessions--only 57% of participants attended at least half of the intervention sessions over the 10 month period, and a higher rate of study withdrawal in the control group.

CONCLUSIONS

This trial does not support the clinical effectiveness or cost-effectiveness of joint reminiscence groups. Possible beneficial effects for people with dementia who attend sessions as planned are offset by raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions.

TRIAL REGISTRATION

ISRCTN Registry ISRCTN42430123.

摘要

背景

让患有痴呆症的人和家庭护理人员共同参与的联合回忆小组很受欢迎,但相关的证据基础有限。本研究旨在评估联合回忆小组相较于常规护理的有效性和成本效益。

方法

这项多中心、实用的随机对照试验有两个平行组:干预组和常规护理对照组。采用了一种受限的动态随机方法,总体分配比例为1:1,进行限制以确保干预组规模可行。在基线、三个月和十个月(主要终点)时进行评估,评估对治疗分配情况保密,评估通常在参与者家中进行。在八个中心招募参与者,主要通过国民保健服务(NHS)记忆诊所和NHS社区心理健康团队。纳入的参与者为社区居住的轻度至中度痴呆症患者(根据《精神疾病诊断与统计手册》第四版,DSM-IV),他们有亲属或其他护理人员定期联系,作为信息提供者,并且愿意且能够参与干预。71%的护理人员为配偶。488名痴呆症患者(平均年龄77.5岁)被随机分组:268人进入干预组,220人进入对照组;350对完成了研究(206对干预组,144对对照组)。所评估的干预措施为联合回忆小组(每组最多12对),每周一次,共十二周;之后每月进行一次维持性活动,持续七个月。活动遵循已发表的治疗手册,在各种社区环境中进行。每个中心有两名经过培训的主持人,并由志愿者提供支持。主要结局指标为痴呆症患者自我报告的生活质量(QoL-AD)、护理人员的心理困扰(一般健康问卷,GHQ-28)。次要结局指标包括:痴呆症患者的自传体记忆和日常生活活动;护理人员的护理压力;双方的情绪、关系质量、服务使用情况和成本。

结果

意向性分析(协方差分析)表明,在主要或次要结局方面,干预组和对照组之间没有差异(自我报告的QoL-AD平均差异为0.07(-1.21至1.35),F = 0.48,p = 0.53)。分配到回忆干预组的痴呆症患者的护理人员在十个月的终点时,在一般健康问卷-28的一个子量表上报告焦虑显著增加(平均差异为1.25(0.25至2.26),F = 8.28,p = 0.04)。依从性分析表明,参加更多回忆活动的痴呆症患者的自传体记忆、生活质量和关系质量有所改善,然而,参加更多小组活动的护理人员的护理压力增加。从公共部门角度进行的经济分析表明,联合回忆小组不太可能具有成本效益。该干预措施未发现显著的不良反应。该研究的潜在局限性包括小组活动的参与率未达最佳——在10个月期间,只有57%的参与者参加了至少一半的干预活动,并且对照组的研究退出率较高。

结论

该试验不支持联合回忆小组的临床有效性或成本效益。按计划参加活动的痴呆症患者可能获得的有益效果被其护理人员增加的焦虑和压力所抵消。这些不一致结果的原因需要进一步探讨,可能需要重新评估联合干预的趋势。

试验注册

国际标准随机对照试验编号(ISRCTN)ISRCTN42430123

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56f6/4836678/3f63d256366a/pone.0152843.g001.jpg

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