促进痴呆症患者的独立性（PRIDE）：一项可行性随机对照试验方案
Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial.
作者信息
Shafayat Aisha, Csipke Emese, Bradshaw Lucy, Charlesworth Georgina, Day Florence, Leung Phuong, Moniz-Cook Esme, Montgomery Alan A, Morris Steve, Mountain Gail, Ogollah Reuben, Sprange Kirsty, Yates Lauren, Orrell Martin
机构信息
Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD, UK.
Division of Psychiatry, University College London, 6th Floor, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.
出版信息
Trials. 2019 Dec 11;20(1):709. doi: 10.1186/s13063-019-3838-x.
BACKGROUND
Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone.
METHODS/DESIGN: PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month's post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined.
DISCUSSION
This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial.
TRIAL REGISTRATION
ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.
背景
记忆服务机构经常接待患有早期痴呆症的患者，这些患者在很大程度上能够独立生活并参与社区活动，但存在减少活动和社交网络的风险。PRIDE是一项自我管理干预措施，旨在促进轻度痴呆症患者的良好生活并增强其独立性。本研究旨在探讨进行一项确定性随机试验的可行性，该试验将比较在常规护理基础上增加PRIDE干预措施与仅采用常规护理的临床效果和成本效益。
方法/设计：PRIDE是一项平行、双臂、多中心、可行性随机对照试验（RCT）。年龄在18岁及以上、患有轻度痴呆症（临床痴呆评定量表评分为0.5或1）、能够参与干预并提供知情同意书的符合条件的参与者将被随机（1:1）分配至在常规护理基础上接受PRIDE干预措施治疗，或仅接受常规护理。参与者将在随机分组后的3个月和6个月进行随访。每个参与者可以选择一名支持者加入。每位支持者将在基线以及3至6个月的随访时收到问卷。对参与者和支持者进行的嵌入式定性研究将探讨他们对干预措施的看法，调查一系列主题，包括可接受性、实施和参与的障碍及促进因素。将考察进行一项全面RCT的可行性，涉及两种情况的参与者招募和随访、干预措施的实施，包括PRIDE培训 facilitators 的招募、培训、留存，临床结局、干预措施和资源使用成本，以及干预措施和与研究相关程序的可接受性。
讨论
本研究将评估一项比较在常规护理基础上增加PRIDE干预措施与仅采用常规护理的临床效果和成本效益的确定性随机试验是否可行，如果可行，将提供数据为未来试验的设计和实施提供参考。
试验注册
ISRCTN，ISRCTN11288961，于2019年10月23日注册，http://www.isrctn.com/ISRCTN12345678 2019年6月19日的协议V2.1。
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