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临床试验/NCT05675137
NCT05675137已完成不适用

Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia

Silvia Health1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks

研究概览

简要总结

This study investigated the efficacy of the Silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. We compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •experiencing subjective cognitive decline,
  • •had a smart phone and could use it, and
  • •understood the purpose and process of this study.

排除标准

  • •major psychiatric disorders
  • •degenerative brain diseases
  • •severe or unstable heart diseases
  • •neurological or psychological diseases that affected cognitive functioning
  • •severe vision or hearing impairment,
  • •current participation in a cognitive training program
  • •does not know how to use mobile devices.

研究组 & 干预措施

paper-based intervention group

Active Comparator

干预措施: paper-based (Other)

Mobile-based multidomain intervention

Experimental

干预措施: mobile-based (Device)

结局指标

主要结局

Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks

时间窗: baseline and after the 12-week intervention

Cognitive function

次要结局

  • Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeks(baseline and after the 12-week intervention)
  • Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks(baseline and after the 12-week intervention)
  • Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks(baseline and after the 12-week intervention)
  • Change from baseline Perceived Stress Scale (PSS) at 12 weeks(baseline and after the 12-week intervention)
  • Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks(baseline and after the 12-week intervention)
  • Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeks(baseline and after the 12-week intervention)

研究者

发起方
Silvia Health
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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