Psychometric Evaluation of the Electronic Pain Assessment Tool PainChek® Adult in Nursing Homes in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PainChek Ltd
- 入组人数
- 105
- 试验地点
- 5
- 主要终点
- Change in pain score using Abbey Pain Scale
研究概览
简要总结
Pain is common amongst people living with dementia. However, as people's dementia worsens their ability to self-report pain diminishes because of limitations in their cognition and communication abilities. As a result pain in people with moderate to severe dementia often goes under-recognised and undertreated.
PainChek® is a technology-enabled, observational pain assessment tool, in the form of a mobile application designed specifically to assist healthcare professionals and professional caregivers assess pain in people with moderate severe dementia. In this study the investigators aim to assess the performance of PainChek® in assessing pain in nursing home residents with moderate to severe dementia compared to the Abbey Pain Scale.
详细描述
Study Design: This is a prospective, multicenter, observational study with the primary objective to validate PainChek® for assessing pain in subjects with moderate-to-severe dementia compared to the Abbey Pain Scale (APS).
In addition, the study data will be used to demonstrate test-retest reliability of the PainChek® device.
Study Objectives: PainChek® has been calibrated and successfully validated against the Abbey Pain Scale in Australia and the United Kingdom. The primary objective of the study is to demonstrate the validity of this calibration in the US intended use population.
As secondary objective, this study will the test-retest reliability of PainChek® as compared to the Abbey Pain Scale (APS).
As an additional exploratory objective, the association between respiratory rate (RR) and heart rate (HR) and pain scores detected by PainChek® and APS will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects enrolled in the study should meet all of the following criteria:
- •have been diagnosed with moderate-to-severe dementia on the basis of the score obtained with one of the following tools:
- •Mini-Mental State Examination (MMSE) score < 19 OR
- •MDS Cognitive Performance Scale (CPS) score > 3 OR
- •Another cognitive assessment tool routinely used within the aged care facility allowing the identification of subjects with moderate-to-severe dementia
- •are unable to reliably self-report pain as determined by the caregiver
- •have been living in the aged care home for at least 30 days prior to the day of screening
- •must have had an informed consent signed by the subject's legally authorized representative
排除标准
- •Subjects enrolled in the study should not meet any of the following criteria:
- •subject is unable to partially or completely exhibit any facial expression (e.g. as a result of a facial palsy, facial injuries or other pathologies)
- •the treating physician determines it is inappropriate to assess the subject for pain
- •subject is currently receiving or has received in the last 30 days prior to screening an investigational product and/or participated in another clinical trial.
结局指标
主要结局
Change in pain score using Abbey Pain Scale
时间窗: Throughout the study on multiple occasions, on average every 7 days
Change in pain measurement using the Abbey Pain Scale with the resident At Rest then Post Movement or vice versa. The scale includes 18 items across 6 domains, with scores of 0-2 representing No Pain, 3-7 Mild Pain, 8-13 Moderate Pain and 14-18 Severe Pain.
Change in pain score using PainChek Adult
时间窗: Throughout the study on multiple occasions, on average every 7 days
Change in pain measurement using PainChek Adult pain scale with the resident At Rest then Post Movement or vice versa. The scale includes 42 items across 6 domains, with scores of 0-6 representing No Pain, 7-11 Mild Pain, 12-15 Moderate Pain and 16-42 Severe Pain.
次要结局
未报告次要终点