个体认知刺激疗法应用于痴呆患者及其照护者的可行性随机对照试验（RCT）研究结果。
An Individual Cognitive Stimulation Therapy App for People with Dementia and Carers: Results from a Feasibility Randomized Controlled Trial (RCT).
机构信息
Department of Computer & Information Sciences, University of Strathclyde, Livingstone Tower, Glasgow, Scotland, G1 1HX, UK.
School of Sociology & Social Policy, Law & Social Sciences Building, University of Nottingham, University Park, Nottingham, England, NG7 2RD, UK.
出版信息
Clin Interv Aging. 2021 Dec 22;16:2079-2094. doi: 10.2147/CIA.S323994. eCollection 2021.
BACKGROUND
There is a lack of digital resources that support the cognition and quality of life (QoL) of people with dementia. The individual cognitive stimulation therapy application (iCST app) aims to provide cognitive stimulation and social interaction to people with dementia and carers through interactive touch-screen technology. This study set out to determine the feasibility of conducting a full-scale, randomized controlled trial (RCT) with the iCST app.
METHODS
This was a single blind, feasibility RCT including people with mild to moderate dementia and their carers. Multiple trial components were assessed including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome assessments which included measures of cognition and QoL. A sample of the intervention group was invited to a semi-structured post-trial interview to examine the experience of using the iCST app.
RESULTS
Sixty-one dyads were randomised to the iCST app (n = 31) or treatment-as-usual (TAU) control group (n = 30) for 11 weeks. In the iCST app group, 77% used the intervention for 20 minutes or more each week. Carers using the iCST app rated their QoL better at follow-up 2 compared to the TAU control group (EQ-5D, MD = 7.69, 95% CI = 2.32-13.06, p = 0.006). No significant differences were found on the other outcome measures.
CONCLUSION
The iCST app was deemed usable and enjoyable. Most participants completed the activities more quickly than anticipated and did not have enough activities to continue using the app frequently. Expansion of the iCST app is needed to maintain engagement for longer. Findings indicate that computerised cognitive stimulation can be beneficial, and a large-scale RCT is feasible with modifications to trial components. The results are relevant to researchers, software developers, policy-makers, people with dementia and carers who are looking to be involved in such interventions.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03282877. Registered on 19 July 2017.
背景
目前缺乏支持痴呆患者认知和生活质量（QoL）的数字资源。个体认知刺激疗法应用程序（iCST 应用程序）旨在通过互动触摸屏技术为痴呆患者和照顾者提供认知刺激和社交互动。本研究旨在确定使用 iCST 应用程序进行全面、随机对照试验（RCT）的可行性。
方法
这是一项单盲、可行性 RCT，纳入了轻度至中度痴呆患者及其照顾者。评估了多个试验组成部分，包括招募和保留率、干预的忠实度和可用性，以及可接受性的结果评估，包括认知和 QoL 测量。干预组的一部分被邀请参加半结构化的试验后访谈，以检查使用 iCST 应用程序的体验。
结果
61 对患者被随机分配到 iCST 应用程序组（n=31）或常规治疗对照组（n=30），进行了 11 周的干预。在 iCST 应用程序组中，77%的患者每周使用干预措施 20 分钟或更长时间。与常规治疗对照组相比，使用 iCST 应用程序的照顾者在随访 2 时报告的生活质量更好（EQ-5D，MD=7.69，95%CI=2.32-13.06，p=0.006）。在其他结果测量上未发现显著差异。
结论
iCST 应用程序被认为是可用且令人愉快的。大多数参与者完成活动的速度比预期的要快，并且没有足够的活动来继续频繁使用该应用程序。需要扩展 iCST 应用程序以保持更长时间的参与度。研究结果表明，计算机化认知刺激可能是有益的，并且可以通过修改试验组成部分来进行大规模 RCT。研究结果与正在研究此类干预措施的研究人员、软件开发人员、政策制定者、痴呆患者和照顾者相关。
试验注册
ClinicalTrials.gov，NCT03282877。于 2017 年 7 月 19 日注册。
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