Vanova Martina, Irazoki Eider, García-Casal J Antonio, Martínez-Abad Fernando, Botella Cristina, Shiells Kate R, Franco-Martín Manuel A
Institute of Biomedical Research, University of Salamanca, Salamanca, Spain.
INTRAS Foundation, Ctra de la Hiniesta 137, 49024, Zamora, Spain.
Trials. 2018 Feb 12;19(1):100. doi: 10.1186/s13063-017-2371-z.
Cognitive rehabilitation is a highly individualised, non-pharmacological intervention for people with mild cognitive impairment (MCI) and dementia, which in recent years has also been developed for various IT platforms.
In this study, we aim to evaluate the effectiveness of the cognitive rehabilitation software GRADIOR in a multi-centre, single-blinded randomised controlled trial with people with MCI and mild dementia. A total of 400 people with MCI and mild dementia will be randomly allocated to one of four groups. This trial will compare the cognitive rehabilitation treatment using the GRADIOR programme with a psychosocial stimulation intervention (PSS) using the ehcoBUTLER platform, with a combined treatment consisting of GRADIOR and ehcoBUTLER, and with a group receiving treatment as usual during a period of 1 year.
The outcomes of this clinical trial will be to determine any relevant changes in cognition, mood, quality of life, activities of daily living and quality of patient-carer relationship after 4 months and 1 year of intervention in a cross-sectional group comparison. Participants will be followed-up for 1 year to investigate potential long-term effects of the conducted treatments.
Current Controlled Trials ISRCTN, ID: 15742788 . Registered on 12 June 2017.
认知康复是针对轻度认知障碍（MCI）和痴呆患者的高度个体化非药物干预措施，近年来也在各种信息技术平台上得到了发展。
在本研究中，我们旨在通过一项针对MCI和轻度痴呆患者的多中心、单盲随机对照试验，评估认知康复软件GRADIOR的有效性。总共400名MCI和轻度痴呆患者将被随机分配到四组中的一组。本试验将把使用GRADIOR程序的认知康复治疗与使用ehcoBUTLER平台的社会心理刺激干预（PSS）、GRADIOR和ehcoBUTLER的联合治疗，以及在1年期间接受常规治疗的组进行比较。
本临床试验的结果将是，在横断面组间比较中，确定干预4个月和1年后认知、情绪、生活质量、日常生活活动以及患者与照顾者关系质量方面的任何相关变化。参与者将被随访1年，以调查所实施治疗的潜在长期影响。
当前对照试验ISRCTN，编号：15742788。于2017年6月12日注册。
