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临床试验/NCT04507633
NCT04507633已完成不适用

The Effect of ROMA Therapy on Improving Cognitive Functions, Depressive Symptoms and Behavioral Problems in the Population With Dementia

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
cognitive functions

研究概览

简要总结

This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in population with dementia. The hypotheis of this study is that these patients with dementia receiving ROMA therapy featuring reminiscence, reality orientation, music, and art would improve their cognition, depressive symptoms, and behavioral symptoms.

详细描述

This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in demented population. A total of 60 patients with mild to moderate dementia will be recruited and randomly assigned to two groups: experimental group and control group. The experimental group will undergo ROMA therapy with a 60 minute per week for eight weeks. The control group will receive three times ROMA therapy after completing outcome measurements. Two groups will receive questionnaire interview at pre-test, post-test, and at 4 weeks after intervention. The measurements comprises: Short Portable Mental Status Questionnaire(SPMSQ), Cornell Scale for Depression in Dementia(CSDD),and Neuropsychiatric Inventory-Questionnaire(NPI-Q). By identifying the effectiveness of ROMA therapy, suitable intervention can be suggested for those demented population to improve cognitive function, behavioral and psychological symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

independent researchers will perform intervention and data collection.

入排标准

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

入选标准

  • Been diagnosed as mild to moderate dementia and CDR score between 0.5~2
  • can communicate in Chinese or Taiwanese
  • without visual or auditory impairment after equipping assist devices

排除标准

  • severe dementia and Clinical Dementia Rating (CDR) score more than 2 points
  • functional dependence
  • incapable of expressing their feelings

结局指标

主要结局

cognitive functions

时间窗: cognitive functions at 4 weeks after the completion of intervention

Short Portable Mental Status Questionnaire(SPMSQ)

depressive symptoms

时间窗: depressive symptoms at 4 weeks after the completion of intervention

Cornell Scale for Depression in Dementia(CSDD)

behavioral problems

时间窗: behavioral problems at 4 weeks after the completion of intervention

Neuropsychiatric Inventory-Questionnaire(NPI-Q)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang, Hui-Chuan

Associate Professor

Taipei Medical University

研究点 (2)

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