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临床试验/NCT04352387
NCT04352387已完成不适用

Effects of a Culturally Adapted Group Based Montessori Based Activities on Engagement and Affect in Chinese Older People With Dementia

Food and Health Bureau, Hong Kong1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2018年8月24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
108
试验地点
1
主要终点
Engagement between the 25th minute - 35th minute of each session

研究概览

简要总结

The objectives of this study are to examine the feasibility of a culturally-adapted group-based Montessori Method for Dementia program in Chinese community and examine its effects on engagement and affect in community-dwelling people with dementia.

详细描述

People who were aged 60 years or over and with mild to moderate dementia were recruited from six community centres and three care homes. Participants were randomly assigned to either the intervention group to attend the Montessori-based activities or the comparison group to attend the conventional group activities for one hour twice per week over eight weeks. All sessions were videotaped to facilitate analysis. Observations of engagement and affect were conducted for each intervention session on the individual participant for a ten-minute period at the beginning, middle, and end of the activity in order to have observations from multiple time points. The Menorah Park Engagement Scale and the Apparent Affect Rating Scale were used to assess the engagement and affect during the activities based on observations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Two research assistants who conducted the observations were blinded to the group allocation.

入排标准

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

入选标准

  • •with a diagnosis of dementia at a stage 3 to 5 on the global deterioration scale (GDS)

排除标准

  • •were joining any other dementia training activities
  • •would highly likely present a hazard to others through disruptive behaviors
  • •proxy consent could not be obtained

研究组 & 干预措施

Montessori Method for Dementia

Experimental

The design of the Montessori Method for Dementia program covered five aspects, namely cognitive stimulation, life skills, motor movements and fitness, sensory stimulation, and socialization. Each 1-hour session included two to three activities tailored to the local cultural context.

干预措施: Montessori Method for Dementia (Behavioral)

Usual care

Active Comparator

Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.

干预措施: Usual care (Behavioral)

结局指标

主要结局

Engagement between the 25th minute - 35th minute of each session

时间窗: through study completion for 8 weeks

Score of Menorah Park Engagement Scale will be used to assess the level of engagement, with the minimum score of 0 and the maximum of 2, with a higher score higher level of engagement.

Engagement between the 1st minute - 10th minute of each session

时间窗: through study completion for 8 weeks

Score of Menorah Park Engagement Scale will be used to assess the level of engagement, with the minimum score of 0 and the maximum of 2, with a higher score higher level of engagement.

Engagement between the 50th minute - 60th minute of each session

时间窗: through study completion for 8 weeks

Score of Menorah Park Engagement Scale will be used to assess the level of engagement, with the minimum score of 0 and the maximum of 2, with a higher score higher level of engagement.

Affect between the 1st minute - 10th minute of each session

时间窗: through study completion for 8 weeks

Score of the Apparent Affect Rating Scale will be used to assess the level of affect, with 1 (Never) to 5 (over 5 minutes), in the aspect of pleasure and interest.

Affect between the 50th minute - 60th minute of each session

时间窗: through study completion for 8 weeks

Score of the Apparent Affect Rating Scale will be used to assess the level of affect, with 1 (Never) to 5 (over 5 minutes), in the aspect of pleasure and interest.

Affect between the 25th minute - 35th minute of each session

时间窗: through study completion for 8 weeks

Score of the Apparent Affect Rating Scale will be used to assess the level of affect, with 1 (Never) to 5 (over 5 minutes), in the aspect of pleasure and interest.

次要结局

未报告次要终点

研究者

发起方
Food and Health Bureau, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Helen YL Chan

Associate Professor

Food and Health Bureau, Hong Kong

研究点 (1)

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