Centre for Applied Dementia Studies, University of Bradford, Bradford, UK.
Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.
Lancet Healthy Longev. 2022 Apr;3(4):e276-e285. doi: 10.1016/S2666-7568(22)00059-9. Epub 2022 Apr 4.
There is an urgent clinical need for evidence-based psychosocial interventions for people with mild dementia. We aimed to determine the clinical benefits and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote wellbeing and independence in people with mild dementia.
We did a single-blind, parallel group, individually randomised, phase 3 trial at 13 National Health Service sites across England. People with mild dementia (Mini-Mental State Examination score of ≥18) who lived in the community were eligible for inclusion. Patients were centrally randomly assigned (1:1) to receive the JtD intervention plus standard care (JtD group) or standard care only (standard care group). Randomisation was stratified by study site. The JtD intervention included 12 group and four one-to-one sessions, delivered in the community at each site. The primary endpoint was Dementia Related Quality of Life (DEMQOL) 8 months after randomisation, assessed according to the intention-to-treat principle. Only outcome assessors were masked to group assignment. A cost-effectiveness analysis reported cost per quality-adjusted life-year (QALY) from a UK NHS and social care perspective. The study is registered with ISRCTN, ISRCTN17993825.
Between Nov 30, 2016, and Aug 31, 2018, 1183 patients were screened for inclusion, of whom 480 (41%) participants were randomly assigned: 241 (50%) to the JtD group and 239 (50%) to the standard care group. Intervention adherence was very good: 165 (68%) of 241 participants in the JtD group attended at least ten of the 16 sessions. Mean DEMQOL scores at 8 months were 93·3 (SD 13·0) for the JtD group and 91·9 (SD 14·6) for the control group. Difference in means was 0·9 (95% CI -1·2 to 3·0; p=0·38) after adjustment for covariates, lower than that identified as clinically meaningful. Incremental cost per QALY ranged from £88 000 to -£205 000, suggesting that JtD was not cost-effective. Unrelated serious adverse events were reported by 40 (17%) patients in the JtD group and 35 (15%) patients in the standard care group.
In common with other studies, the JtD intervention was not proven effective. However, this complex trial successfully recruited and retained people with dementia without necessarily involving carers. Additionally, people with dementia were actively involved as participants and study advisers throughout. More research into methods of measuring small, meaningful changes in this population is needed. Questions remain regarding how services can match the complex, diverse, and individual needs of people with mild dementia, and how interventions to meet such needs can be delivered at scale.
UK National Institute of Health Research Health Technology Assessment Programme.
目前迫切需要针对轻度痴呆症患者的循证社会心理干预措施。我们旨在确定 Journeying through Dementia（JtD）干预措施的临床获益和成本效益，该干预措施旨在促进轻度痴呆症患者的幸福感和独立性。
我们在英格兰 13 个国民保健署（NHS）地点进行了一项单盲、平行组、个体随机、3 期试验。有轻度痴呆症（Mini-Mental State Examination 评分≥18）且居住在社区的患者有资格入组。患者被中央随机分配（1:1）接受 JtD 干预加标准护理（JtD 组）或仅接受标准护理（标准护理组）。随机化按研究地点分层。JtD 干预包括在每个地点的社区进行 12 次小组和 4 次一对一的会议。主要终点是随机分组后 8 个月的痴呆相关生活质量（DEMQOL），根据意向治疗原则进行评估。只有结局评估者对分组情况设盲。一项成本效益分析报告了从英国国民保健署和社会护理角度来看的每质量调整生命年（QALY）的成本。该研究在 ISRCTN 注册，注册号为 ISRCTN17993825。
2016 年 11 月 30 日至 2018 年 8 月 31 日，共筛查了 1183 名患者，其中 480 名（41%）患者被随机分配：241 名（50%）分入 JtD 组，239 名（50%）分入标准护理组。干预依从性非常好：241 名 JtD 组患者中有 165 名（68%）参加了至少 16 次会议中的 10 次。JtD 组 8 个月时的平均 DEMQOL 评分是 93.3（SD 13.0），对照组为 91.9（SD 14.6）。调整协变量后，两组之间的差值为 0.9（95%CI -1.2 至 3.0；p=0.38），低于被认为有临床意义的差值。增量成本每 QALY 范围从 88000 英镑到-205000 英镑不等，表明 JtD 没有成本效益。JtD 组有 40 名（17%）患者和标准护理组有 35 名（15%）患者报告了无关的严重不良事件。
与其他研究一样，JtD 干预措施并未被证明有效。然而，这项复杂的试验成功地招募并保留了痴呆症患者，而无需一定涉及照料者。此外，痴呆症患者作为参与者和研究顾问在整个过程中都积极参与。需要进一步研究如何衡量这一人群中微小、有意义的变化的方法。如何服务能够满足轻度痴呆症患者的复杂、多样和个体需求，以及如何大规模提供满足这些需求的干预措施，这些问题仍然存在。
英国国家卫生研究院健康技术评估计划。
