ACTRN12623000350628招募中Unknown
Music Attuned Technology for Care via eHealth – MATCH: Determining Digital Markers of Agitation (Study 3 - Stage 2)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •Resident (full-time, 24 hours/day) at a participating RAC
- •Documented diagnosis of dementia (any aetiology)
- •Dementia Severity Rating Scale score >18
- •NPI-NH: Severity score >6
- •Has given written informed consent (or verbal assent with written consent by proxy for those legally unable to provide consent themselves)
- •Presence of at least 1 agitation symptom occurring at least several times a day (rated on the CMAI)
- •Able to tolerate wearing sensors, based on care staff clinical knowledge about the resident
- •Does not have severe aggression (NPI-NH score is less than 3 on agitation and aggression scale)
- •Does not have a severe medical illness and/or life-threatening condition, as assessed by study doctors
- •No known allergy to components in the Empatica (anodized aluminum, polycarbonate, SUS316L, 304 stainless steel, polyurethane; see https://support.empatica.com/hc/en-us/articles/115000195083-Embrace-materials)
- •Does not have delirium
- •Has no or low risk of pressure injuries (rated on Braden Risk Assessment score of 13 or higher)
排除标准
- •Residents for whom there is a risk associated with them wearing the sensors
- •Residents who refuse to wear the sensors
- •Residents with hyperorality, who frequently place items in their mouth
- •Residents whose mental state may be impacted by wearing the sensors (as assessed by care staff)
- •Residents with known paranoid or delusional ideas
- •Residents for whom the RAC staff overseeing their care believes participation would be contraindicated
研究者
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