Department of Neuropsychiatry, Keio University School of Medicine, Center for Stress Research, Keio University, Tokyo, Japan.
Department of Social Policy, London School of Economics and Political Science, London, UK.
J Alzheimers Dis. 2020;74(3):775-784. doi: 10.3233/JAD-190886.
Although the effects of various types of cognitive interventions have been evaluated, effectiveness and cost-saving effect of the combination of the different cognitive interventions is unknown.
This study aimed to evaluate the feasibility of conducting a definitive trial to assess the effectiveness of combined cognitive intervention.
A matched controlled trial of learning therapy (LT), a combination of cognitive training and stimulation, was conducted. The samples were recruited from the nursing homes. Inclusion criteria were as follows: age 65 years or older, clinical diagnosis of dementia, level of activities of daily living at II or above, Mini-Mental State Examination score between 10 and 26, receiving long-term-care services without history of LT, and provision of written consent. The primary outcomes were safety, validity of eligibility, retention rate, and effect on the functions of daily living represented by Criterion Time for Certification of Needed Long-Term-Care (CT for CNLTC) at 12 months. Cost-benefit analysis was also conducted to assess the cost saving effect of LT.
No serious adverse events were detected. The exclusion rate at the screening phase was 5% and the retention rate was 77% at 12 months. LT demonstrated statistically significant improvement in CT for CNLTC at 12 months (Δ=18.8, almost equivalent to "one" degree of the care needed level) and saved the long-term-care cost by JPY 200,000 (USD 1,618).
LT is effective for improving care recipients' level of care needed and has a cost saving effect. A randomized controlled trial is required to verify these findings.
This study was approved by the ethics committee at Keio University School of Medicine (ID: 20150061). This trial was registered at University hospital Medical Information Network Clinical Trial Registry (UMIN-CTR ID: UMIN000018223).
虽然已经评估了各种类型认知干预的效果，但不同认知干预相结合的有效性和节省成本的效果尚不清楚。
本研究旨在评估进行一项评估联合认知干预效果的确证性试验的可行性。
进行了一项学习疗法（LT）的配对对照试验，即认知训练和刺激的结合。样本从养老院招募。纳入标准如下：年龄 65 岁或以上、临床诊断为痴呆、日常生活活动水平 II 级或以上、简易精神状态检查评分 10 至 26 分、接受长期护理服务但无 LT 史、并提供书面同意。主要结局为安全性、入选标准的有效性、保留率以及 12 个月时以需要长期护理认证的标准时间（CT for CNLTC）表示的日常生活功能的影响。还进行了成本效益分析，以评估 LT 的成本节省效果。
未发现严重不良事件。在筛选阶段的排除率为 5%，12 个月时的保留率为 77%。LT 在 12 个月时 CT for CNLTC 有统计学显著改善（Δ=18.8，几乎相当于“一级”护理需求水平），并节省了 2000000 日元（1618 美元）的长期护理费用。
LT 有效改善了护理接受者的护理需求水平，并具有节省成本的效果。需要进行随机对照试验来验证这些发现。
本研究经庆应义塾大学医学院伦理委员会批准（注册号：20150061）。本试验在大学医院医疗信息网络临床试验注册中心（UMIN-CTR 注册号：UMIN000018223）注册。
