Measuring the Impact of Socially Assistive Robot on Older Adults With MCI and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline Active Engagement at month 6
研究概览
简要总结
Due to increasing age and an increasing prevalence rate of neurocognitive disorders such as Mild Cognitive Impairment and dementia, independent living may become challenging. The use of socially assistive robots is one solution that can enable older adults with cognitive impairment to remain independent. However, at present, there is a lack of knowledge about the impact of assistive robots on older adults with MCI and their caregivers. A 12-month trial will be conducted to measure the impact of the robot. A total of 120 participants living in independent living facilities, nursing homes or patients part of a rehabilitation program will be recruited. The outcome measures will be defined based on experiences from previous pilot trials with the robot. The primary outcomes will be active engagement and loneliness. Participation, physical and cognitive functioning will be defined as the secondary outcomes.
详细描述
The objective of the current study is to evaluate the impact of the robot using a cross-over design.
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Recruitment An existing database with facilities, built up in the previous phases of the project, will be used to recruit new participants. Sample Size calculations were done a priori using G*Power, based on an effect size of 0.4 and testing the difference between two dependent means. According to these calculations, a total sample size of 62 would allow us to detect significant differences among the mean values on the primary outcome measures (α =.025 and power =.8).
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Handling Missing Data Since the reason for dropouts might be of great importance for the results of this study, they will be taken into account. Therefore, the Intention To Treat (ITT) approach will be applied.
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Data Analysis
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Quantitative Analysis
Descriptive statistics will be employed to describe the characteristics of the participants. Distribution of data will be assessed by inspecting the histograms and by appropriate tests, e.g. Shapiro-Wilk Test. Data will be visualized using bar charts (categorical variables) and/or box plots (continuous variables). If appropriate, independent t-tests will be used at baseline data to investigate whether or not there are significant differences between both groups. Alternatively, in case of non-normal distributed data, Mann Whitney-U tests will be applied instead.
Active Engagement Evaluation will be performed at baseline, after 3 months, 6 months, 9 months and 12 months in the study with both group A and B. Primary endpoint is the comparison "no robot" vs "robot" at 6 months within that period. Active Engagement will be calculated by comparing the data of the intervention and control group after 6 months and 12 months with counts (the number of times the person shows a certain behavior at a certain time point during the activity) as the outcome variable. Data will be analyzed using a mixed negative binominal regression, with the subjects considered the random factor and the following variables as fixed effects: (1) condition (robot vs no robot), (2) time (baseline, 3 and 6 months) and (3) interaction between condition and time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- •Score range of 19/30 - 25/30 on Montreal Cognitive Assessment (MoCA)
- •Ability to walk independently with or without assistive device
排除标准
- •Health conditions that do not allow participation in a physical intervention
- •Planned surgery or hospitalisation within 12 months of the trial
- •Insufficient language skills
- •History of severe neurological (e.g. stroke) or psychiatric (e.g. depression) condition
- •Severe vision impairment / hearing loss
- •Participation in another study to test a new technology
结局指标
主要结局
Change from baseline Active Engagement at month 6
时间窗: baseline, month 6
Active engagement will be assessed using a time-sampling method. A scoring form will be adapted based on a protocol called 'Video Coding Incorporating Observed Emotion' (VC-IOE).
Change from baseline Loneliness at month 6
时间窗: baseline, month 6
Loneliness will be assessed by De Jong-Gierveld 11-item Loneliness Scale. Scores range between 0-11 points, with a higher score indicating stronger feelings of loneliness. Score 0-2: not lonely, score 3-11: lonely. Within the lonely people, a distinction can be made between moderate lonely people (scoring 3 to 8) and strong lonely people (scoring 9 to 11). The instrument is divided into two subscales: emotional and social loneliness. Social loneliness occurs when someone is missing a wider social network. Emotional loneliness refers to missing an "intimate" relationship or friendship.
次要结局
- Change from baseline Participation level at month 6(baseline, month 6)
- Change from baseline Physical functioning at month 6(baseline, month 6)
- Change from baseline Cognitive functioning at month 6(baseline, month 6)