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临床试验/NCT03379519
NCT03379519已完成不适用

The Development and Evaluation of Multi-domain Attention Training for Older Adults With Mild Cognitive Impairment

Ministry of Science and Technology, Taiwan0 个研究点目标入组 60 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Change in attention as measured by the Digit Span Task (DS).

研究概览

简要总结

This study sought to investigate the changes in attention in older adults with mild cognitive impairment after Multi-domain Attention Training .

详细描述

This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Multi-domain Attention Training, MAT), or active control group (Passive information activities, PIA). Training sessions of the MAT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as MAT group. The investigators constructed a rigorous MAT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in attention function of older adults with mild cognitive impairment after using the MAT program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
  • Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
  • Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher
  • No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family

排除标准

  • The clinical diagnosis of dementia was based on the DSM-IV-TR
  • Active in another cognitive or memory-related training in the past year
  • Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
  • A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
  • Severe losses in vision, hearing, or communicative ability

结局指标

主要结局

Change in attention as measured by the Digit Span Task (DS).

时间窗: Change from baseline in executive attention at Immediate post-test, 3 months, 6 months after intervention.

The primary outcome indicators is executive attention assessed by the Digit Span Task (DS).

次要结局

  • Change in attention as measured by the Trail Making Test (TMT).(Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months after intervention.)

研究者

发起方
Ministry of Science and Technology, Taiwan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yang, Hui-Ling

Ph.D. candidate

Ministry of Science and Technology, Taiwan

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Protocol of Multi-domain Attention Training | 临床试验