A Pilot Study of an Interactive Digital Technology (MindfulGarden) in Treatment of Hyperactive Delirium in a Hospital Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 主要终点
- Recruitment Rates
研究概览
简要总结
This pilot study is designed to address feasibility for a larger randomized control clinical study that will determine the efficacy of exposure to the MindfulGarden - an interactive digital technology - in reducing hyperactive delirium in hospitalized older adults.
详细描述
The primary objective of the study is to establish whether the key components necessary for conducting a full randomized control study in the future, such as recruitment, consent, randomization, and treatment processes are working well and all function together. As a secondary objective, the investigators will determine trends in patients exposed to MindfulGarden (MG), for example:
- At the first and second administration of the Confusion Assessment Method - short form (CAM) after admission to a medical ward are there more, the same or fewer patients in the intervention group than in the control group whose CAM scores change from positive to negative?
- During the first 24 hours after admission to a medical ward, did fewer, the same, or a greater number of patients in the intervention than in the control group experience significant events/alerts (e.g. aggressive/violent behaviours, falls, code white)?
- During the first 24 hours after admission to a medical ward, were fewer, the same, or a greater number of patients in the intervention than in the control group administered psychotropic drugs (e.g. haloperidol, risperidone, quetiapine, lorazepam)? were more, the same, or fewer administered sleeping aids (e.g. trazodone, melatonin)?
- During the first 24 hours after admission to a medical ward, were fewer, the same, or a greater number of patients in the intervention than in the control group physically restrained?
- Was mean length of stay from time of admission to a medical ward until discharge due to death, return to place of residence before admission or to a different place of residence longer, the same or shorter in the intervention than in the control group?
- Were there more, the same or fewer deaths or discharges to a higher level of care (e.g. to assisted living, to a complex care facility in patients who previously lived at home) in the intervention than the control group?
Additionally, to the extent that movement and vocalization are reflective of anxiety, agitation and/or aggression (i.e. responsive behaviours) the investigators also want to determine whether there is a correlation between changes in these as recorded by the MG and any of the indicators listed in 1-6 above.
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)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 65 years or older admitted to the Emergency Department who have a diagnosis of hyperactive delirium as defined by the short CAM
排除标准
- •Patients with severe vision impairment or who are legally blind
- •Patients for whom a bed in a medical ward was not available within 12 hours of a diagnosis of hyperactive delirium (i.e. who remained in the Emergency Department more than 12 hours)
研究组 & 干预措施
MindfulGarden
Standard care + exposure to an interactive digital device
干预措施: MindfulGarden (Device)
Control
Standard care only
结局指标
主要结局
Recruitment Rates
时间窗: Number enrolled within 12 hours of admission to Emergency Department
Number of participants approached and their rate of consent
次要结局
- Estimate the potential effect size(24-hour period following transfer from Emergency Department)
- Adverse Outcomes (number of patients with aggressive/violent behaviours, falls, code white)(24-hour period following transfer from Emergency Department)
- Length of Stay(Date of study enrolment through to discharge from hospital, or date of study enrolment up to 30 days)
- Psychotropic Drug Consumption(24-hour period following transfer from Emergency Department)
- Application of Physical Restraints(24-hour period following transfer from Emergency Department)
研究者
Gloria Gutman
Professor Emerita
Simon Fraser University