跳至主要内容
临床试验/NCT03494699
NCT03494699Unknown不适用

Effects of App-based Cognitive Training on Cognition in Community Dwelling Elderly Using: A Randomized Controlled Trial

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Change from Baseline Cognition at 6 month

研究概览

简要总结

This randomized controlled trial is for investigating the effects of multidisciplinary intervention program on cognition and activity of daily living ability in community dwelling healthy elderly. The intervention consists of cognitive group training every month, daily home cognitive training using cognitive training smartphone application, record of weekly physical activity and body weight and feedback program, and alcohol and smoking cessation monitoring and feedback program. Among these interventions, app-based cognitive training at home is the major intervention in this study. The total duration of intervention is 1 year, and the tablet-based cognitive screening test and the patient-reported questionnaires to evaluate subjective memory decline, quality of life, depression, and activity of daily living are used for outcome measures.

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
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • education years >= 6 years
  • not demented
  • mini-mental status examination >= 24
  • android cellular phone users
  • no significant decline in activities of daily living (Korea- Instrumental Activities of Daily Living =<5)

排除标准

  • Who has a history of major cardiovascular diseases within 3 months of study enrollment (ex. myocardial infarction, stroke)
  • Who has current illnesses that could possibly affect cognition or with anticipated life expectancy of less than 2 years (ex. end stage cancer, on chemotherapy)
  • Who has a severe hearing difficulty or visual disturbance
  • Who has a limitation in communication
  • Who was diagnosed with dementia
  • Who has a plan for immigration or move in 1.5 years after study enrollment
  • Who underwent a cognitive training within 6 months of study enrollment

研究组 & 干预措施

Intervention group

Experimental

干预措施: Multidisciplinary prevention (Behavioral)

Control group

No Intervention

结局指标

主要结局

Change from Baseline Cognition at 6 month

时间窗: Baseline, 6months

Table-based cognitive screening test score

Change from Baseline Cognition at 1 year

时间窗: Baseline, 1year

Table-based cognitive screening test score

次要结局

  • Change in Depression(Baseline, 6months, 1year)
  • Change in Quality of life measures(Baseline, 6months, 1year)
  • Change in Stress(Baseline, 6months, 1year)
  • Change in Prospective and retrospective memory(Baseline, 6months, 1year)
  • Change in Activities of Daily Living(Baseline, 6months, 1year)
  • Change in Dementia Screening Questionnaire score(Baseline, 6months, 1year)
  • Change in anxiety(Baseline, 6months, 1year)
  • Change in Subjective memory(Baseline, 6months, 1year)
  • Change in Mastery(Baseline, 6months, 1year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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