Centre for Applied Dementia Studies, University of Bradford, Bradford, UK.
Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Sheffield, UK.
Health Technol Assess. 2022 May;26(24):1-152. doi: 10.3310/KHHA0861.
There are few effective interventions for dementia.
To determine the clinical effectiveness and cost-effectiveness of an intervention to promote self-management, independence and self-efficacy in people with early-stage dementia.
To undertake a randomised controlled trial of the Journeying through Dementia intervention compared with usual care, conduct an internal pilot testing feasibility, assess intervention delivery fidelity and undertake a qualitative exploration of participants' experiences.
A pragmatic two-arm individually randomised trial analysed by intention to treat.
A total of 480 people diagnosed with mild dementia, with capacity to make informed decisions, living in the community and not participating in other studies, and 350 supporters whom they identified, from 13 locations in England, took part.
Those randomised to the Journeying through Dementia intervention ( = 241) were invited to take part in 12 weekly facilitated groups and four one-to-one sessions delivered in the community by secondary care staff, in addition to their usual care. The control group ( = 239) received usual care. Usual care included drug treatment, needs assessment and referral to appropriate services. Usual care at each site was recorded.
The primary outcome was Dementia-Related Quality of Life score at 8 months post randomisation, with higher scores representing higher quality of life. Secondary outcomes included resource use, psychological well-being, self-management, instrumental activities of daily living and health-related quality of life.
Participants were randomised in a 1 : 1 ratio. Staff conducting outcome assessments were blinded.
Outcome measures were administered in participants' homes at baseline and at 8 and 12 months post randomisation. Interviews were conducted with participants, participating carers and interventionalists.
The mean Dementia-Related Quality of Life score at 8 months was 93.3 (standard deviation 13.0) in the intervention arm ( = 191) and 91.9 (standard deviation 14.6) in the control arm ( = 197), with a difference in means of 0.9 (95% confidence interval -1.2 to 3.0; = 0.380) after adjustment for covariates. This effect size (0.9) was less than the 4 points defined as clinically meaningful. For other outcomes, a difference was found only for Diener's Flourishing Scale (adjusted mean difference 1.2, 95% confidence interval 0.1 to 2.3), in favour of the intervention (i.e. in a positive direction). The Journeying through Dementia intervention cost £608 more than usual care (95% confidence interval £105 to £1179) and had negligible difference in quality-adjusted life-years (-0.003, 95% confidence interval -0.044 to 0.038). Therefore, the Journeying through Dementia intervention had a mean incremental cost per quality-adjusted life-year of -£202,857 (95% confidence interval -£534,733 to £483,739); however, there is considerable uncertainty around this. Assessed fidelity was good. Interviewed participants described receiving some benefit and a minority benefited greatly. However, negative aspects were also raised by a minority. Seventeen per cent of participants in the intervention arm and 15% of participants in the control arm experienced at least one serious adverse event. None of the serious adverse events were classified as related to the intervention.
Study limitations include recruitment of an active population, delivery challenges and limitations of existing outcome measures.
The Journeying through Dementia programme is not clinically effective, is unlikely to be cost-effective and cannot be recommended in its existing format.
Research should focus on the creation of new outcome measures to assess well-being in dementia and on using elements of the intervention, such as enabling enactment in the community.
This trial is registered as ISRCTN17993825.
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 26, No. 24. See the NIHR Journals Library website for further project information.
目前针对痴呆症的有效干预措施较少。
确定一项针对早期痴呆症患者促进自我管理、独立和自我效能的干预措施的临床效果和成本效益。
对 Journeying through Dementia 干预措施与常规护理进行随机对照试验，进行内部试点可行性测试，评估干预措施的实施保真度，并对参与者的体验进行定性探索。
一项实用的两臂个体随机试验，按意向治疗进行分析。
来自英国 13 个地点的 480 名被诊断为轻度痴呆症、有能力做出明智决策、居住在社区且未参加其他研究的患者及其他们指定的 350 名支持者参加了试验。
被随机分配到 Journeying through Dementia 干预组（n=241）的参与者被邀请参加 12 次每周的小组活动和 4 次由二级保健工作人员在社区进行的一对一课程，此外还接受常规护理。对照组（n=239）接受常规护理。常规护理包括药物治疗、需求评估和转介到适当的服务。每个地点的常规护理均有记录。
主要结局指标是随机分组后 8 个月的痴呆症相关生活质量评分，得分越高表示生活质量越高。次要结局指标包括资源利用、心理健康、自我管理、日常生活活动的工具性和健康相关的生活质量。
参与者按 1:1 的比例随机分组。进行结局评估的工作人员是盲法的。
基线时、随机分组后 8 个月和 12 个月在参与者家中进行了结局测量。对参与者、参与的照顾者和干预者进行了访谈。
干预组（n=191）的平均痴呆症相关生活质量评分为 8 个月时的 93.3（标准差 13.0），对照组（n=197）为 91.9（标准差 14.6），调整后两组之间的差异为 0.9（95%置信区间 -1.2 至 3.0；=0.380）。这个效应大小（0.9）小于定义为具有临床意义的 4 分。对于其他结局，只有在 Diener 的繁荣量表上发现了差异（调整后的平均差异 1.2，95%置信区间 0.1 至 2.3），有利于干预组（即朝着积极的方向）。Journeying through Dementia 干预措施比常规护理费用高出 608 英镑（95%置信区间 105 至 1179 英镑），在质量调整生命年方面的差异可以忽略不计（-0.003，95%置信区间 -0.044 至 0.038）。因此，Journeying through Dementia 干预措施的每质量调整生命年增量成本为-202857 英镑（95%置信区间 -534733 至-483739 英镑）；然而，这方面存在很大的不确定性。评估的保真度很好。接受访谈的参与者描述了从中获得了一些益处，少数人受益很大。然而，少数人也提出了一些负面方面。干预组中有 17%的参与者和对照组中有 15%的参与者经历了至少一次严重不良事件。没有任何严重不良事件被归类为与干预相关。
研究的局限性包括招募了一个活跃的人群、交付方面的挑战以及现有结局测量的局限性。
Journeying through Dementia 方案在临床效果上没有优势，不太可能具有成本效益，不能以现有的形式推荐。
研究应集中于创建新的结局测量来评估痴呆症的幸福感，并利用干预措施的要素，例如在社区中促进实施。
该试验在英国临床试验注册中心（ISRCTN）注册，注册号为 ISRCTN85321063。
本项目由英国国家卫生与保健优化研究所（NIHR）卫生技术评估计划资助，全文将在 ; Vol. 26, No. 24 中发表。有关该项目的更多信息，请访问 NIHR 期刊库网站。
