The Development and Evaluation of the Effectiveness of a Virtual Interactive Memory Training Program for Older Adults With Mild Cognitive Impairment: Protocol of a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).
研究概览
简要总结
This study sought to investigate the changes in objective memory performance (including immediate recall and delayed recall), subjective memory complaints and degree of depression in older adults with mild cognitive impairment after Virtual interactive memory training (VIMT).
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 (Virtual interactive memory training, VIMT), or active control group (Passive information activities, PIA). Training sessions of the VIMT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as VIMT group. We constructed a rigorous VIMT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in memory function and degree of depression of older adults with mild cognitive impairment after using the VIMT.
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
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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, and cut-off score of 23/24 on the Montreal Cognitive Assessment (MoCA)
- •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
研究组 & 干预措施
Virtual interactive memory training
Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each).
干预措施: Virtual interactive memory training (Behavioral)
Passive information activities
The training of active control group is the same as VIMT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions). The active control group receives only the initial training.
干预措施: Passive information activities (Behavioral)
结局指标
主要结局
Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).
时间窗: Change from baseline in objective memory performance at Immediate post-test, 3 months, 6 months and one year after intervention.
次要结局
- Change in subjective memory complaints as measured by the Multifactorial Memory Questionnaire (MMQ).(Change from baseline in subjective memory complaints at Immediate post-test, 3 months, 6 months and one year after intervention.)
研究者
Yang, Hui-Ling
Ph.D. candidate
Ministry of Science and Technology, Taiwan