Division of Psychiatry, University College London, London, UK.
Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Clin Interv Aging. 2021 Feb 25;16:363-378. doi: 10.2147/CIA.S281139. eCollection 2021.
There is a need for interventions to foster and maintain independence for people with dementia to support community living, improve morale, and reduce stigma. We investigated a social intervention to promote living well and enhance independence for people with mild dementia.
In this two arm parallel group, feasibility RCT at six sites in England, participants were randomized (1:1) to the PRIDE intervention (encompassing social, physical, and cognitive domains supported by a facilitator over three sessions) compared to usual care only. The main objective was to determine the feasibility of a main trial with respect to measures of recruitment, retention, and adherence to the intervention.
During a 7-month period, 402 people were invited to the trial, 148 were screened (37%, 95% confidence interval (CI)=32-42%), 137 were eligible at pre-consent, 94 consented to the trial (69% of those eligible, 95% CI=60-76%), and 92 were randomized (46 to each group). Of those allocated to the intervention, 42 (91%) received at least one of three intervention sessions. Outcome assessment follow-up visits were completed for 73 participants at 6 months (79%, 95% CI=70-87%), and this was similar for both groups.
A large multi-center trial of the PRIDE intervention in community-dwelling people with mild dementia is feasible using systematic recruitment strategies. The intervention was successfully delivered and well received by participants. Findings from this study will be used to refine the design and processes for a definitive RCT.
ISRCTN, ISRCTN11288961, registered on 23 October 2018.
需要采取干预措施来培养和维持痴呆症患者的独立性，以支持他们的社区生活、提高士气并减少耻辱感。我们研究了一种促进轻度痴呆症患者生活幸福和增强独立性的社会干预措施。
在英格兰六个地点进行的这项 2 臂平行组可行性 RCT 中，参与者按照 1:1 的比例随机分配到 PRIDE 干预组（包括社会、身体和认知领域，由一名促进者在三个疗程中提供支持）与仅接受常规护理相比。主要目标是确定一项主要试验的可行性，包括招募、保留和对干预措施的依从性方面的措施。
在 7 个月的时间里，共有 402 人受邀参加试验，148 人接受了筛查（37%，95%置信区间（CI）=32-42%），137 人在预同意前合格，94 人同意参加试验（合格人数的 69%，95%CI=60-76%），92 人被随机分配（每组 46 人）。在被分配到干预组的人中，有 42 人（91%）至少接受了三个干预疗程中的一个。有 73 名参与者在 6 个月时完成了结果评估随访（79%，95%CI=70-87%），两组的情况相似。
使用系统的招募策略，对社区居住的轻度痴呆症患者进行 PRIDE 干预的大型多中心试验是可行的。该干预措施成功地为参与者提供了服务，并受到了他们的欢迎。这项研究的结果将用于改进一项确定性 RCT 的设计和流程。
ISRCTN，ISRCTN11288961，于 2018 年 10 月 23 日注册。
