DREAMS START（痴呆症相关睡眠手册；亲属策略）与痴呆症患者及其照护者常规照护的临床效果：单掩蔽、第 3 阶段、平行臂、优越性随机对照试验。

IF 13.4 Q1 GERIATRICS & GERONTOLOGY

Lancet Healthy Longevity Pub Date : 2024-10-01 DOI:10.1016/j.lanhl.2024.08.004

Prof Penny Rapaport PhD , Sarah Amador PhD , Mariam O Adeleke PhD , Prof Julie A Barber PhD , Prof Sube Banerjee MD , Prof Georgina Charlesworth PhD , Chris Clarke DClinPsy , Prof Colin A Espie DSc , Lina Gonzalez MSc , Rossana Horsley GradCert , Prof Rachael Hunter MSc , Prof Simon D Kyle PhD , Monica Manela BM , Malgorzata Raczek PhD , Prof Zuzana Walker MD , Lucy Webster PhD , Hang Yuan PhD , Prof Gill Livingston MD

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引用次数: 0

摘要

背景：睡眠障碍是痴呆症患者及其家人常见的困扰。非药物干预应作为一线治疗方法，以避免有害的药物副作用，但目前尚无有效的干预方法。我们旨在确定，与常规护理相比，DREAMS START（一种多成分干预措施）是否能减少居家痴呆症患者的睡眠障碍：我们开展了一项第三阶段、双臂、多中心、平行臂、优越性随机对照试验，对结果进行了掩蔽评估，招募了社区中患有痴呆症和睡眠障碍的患者及其家庭照顾者。DREAMS START干预（加常规治疗）或常规治疗的随机分配是在二人一组的基础上进行的，通过网络系统进行分配。DREAMS START 是一项为期六节的人工干预，由未接受过临床培训的毕业生在约三个月的时间内通过面对面或远程的方式进行。主要结果是8个月后通过睡眠障碍量表（SDI）测量的睡眠障碍。分析对象为意向治疗人群。该试验的注册号为 ISRCTN 13072268：2021年2月24日至2023年3月5日期间，377对夫妇被随机分配（1:1），其中189对接受常规治疗，188对接受干预治疗。痴呆症患者的平均年龄为 79-4 岁（SD 9-0），其中 206 人（55%）为女性。与常规治疗组相比，干预组在8个月时的SDI平均得分较低（15-16 [SD 12-77]，n=159，vs 20-34 [16-67]，n=163]；调整后的平均值差异为-4-70 [95% CI -7-65 to -1-74], p=0-002）。干预组中有17名（9%）痴呆症患者在试验期间死亡，对照组中有17名（9%）患者在试验期间死亡，死亡原因与干预无关：据我们所知，"DREAMS START "是第一项多成分干预措施，与常规临床护理相比，它能更有效地改善居家痴呆症患者的睡眠。该干预措施在实施后仍能持续有效。该干预措施由未接受过临床培训的毕业生实施，这增加了在医疗服务中实施的可能性，同时也是对常规临床护理的补充：国家健康与护理研究所健康技术评估。

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Clinical effectiveness of DREAMS START (Dementia Related Manual for Sleep; Strategies for Relatives) versus usual care for people with dementia and their carers: a single-masked, phase 3, parallel-arm, superiority randomised controlled trial

Background

Sleep disturbances are common and distressing for people with dementia and their families. Non-pharmacological interventions should be first-line management, avoiding harmful pharmacological side-effects, but there is none with known effectiveness. We aimed to establish whether DREAMS START, a multicomponent intervention, reduced sleep disturbance in people with dementia living at home compared with usual care.

Methods

We conducted a phase 3, two-arm, multicentre, parallel-arm, superiority randomised controlled trial with masked outcome assessment, recruiting dyads of people with dementia and sleep disturbance and family carers from community settings. Randomisation to the DREAMS START intervention (plus usual treatment) or usual treatment was conducted at dyadic level, blocked, and stratified by site, with a web-based system assigning allocation. DREAMS START is a six-session, manualised intervention delivered face to face or remotely by non-clinically trained graduates over an approximately 3-month period. The primary outcome was sleep disturbance measured by the Sleep Disorders Inventory (SDI) at 8 months. Analyses were on the intention-to-treat population. This trial is registered with ISRCTN 13072268.

Findings

Between Feb 24, 2021, and March 5, 2023, 377 dyads were randomly assigned (1:1), 189 to usual treatment and 188 to intervention. The mean age of participants with dementia was 79·4 years (SD 9·0), and 206 (55%) were women. The mean SDI score at 8 months was lower in the intervention group compared with the usual treatment group (15·16 [SD 12·77], n=159, vs 20·34 [16·67], n=163]; adjusted difference in means –4·70 [95% CI –7·65 to –1·74], p=0·002). 17 (9%) people with dementia in the intervention group and 17 (9%) in the control group died during the trial; the deaths were unrelated to the intervention.

Interpretation

To our knowledge, DREAMS START is the first multicomponent intervention to improve the sleep of people living at home with dementia more than usual clinical care. It had sustained effectiveness beyond intervention delivery. The intervention’s delivery by non-clinically trained graduates increases the potential for implementation within health services, adding to usual clinical care.

Funding

National Institute for Health and Care Research Health Technology Assessment.

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来源期刊

Lancet Healthy Longevity GERIATRICS & GERONTOLOGY-

CiteScore

16.30

自引率

2.30%

发文量

192

审稿时长

12 weeks

期刊介绍： The Lancet Healthy Longevity, a gold open-access journal, focuses on clinically-relevant longevity and healthy aging research. It covers early-stage clinical research on aging mechanisms, epidemiological studies, and societal research on changing populations. The journal includes clinical trials across disciplines, particularly in gerontology and age-specific clinical guidelines. In line with the Lancet family tradition, it advocates for the rights of all to healthy lives, emphasizing original research likely to impact clinical practice or thinking. Clinical and policy reviews also contribute to shaping the discourse in this rapidly growing discipline.