AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose and Endurance in Palliative Care for Dementia: Pilot Study 1 Digital Toolkit Assessment
概览
- 阶段
- 不适用
- 干预措施
- Digital toolkit for assessment
- 疾病 / 适应症
- Dementia
- 发起方
- University of Bonn
- 入组人数
- 150
- 主要终点
- Feasibility and acceptability of toolkit
- 状态
- 尚未招募
- 最后更新
- 2个月前
概览
简要总结
The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia.
详细描述
The clinical study is part of an EU-funded project on the use of artificial intelligence for patients with dementia. This study will test a digital toolkit fo assessment and monitoring of patients with mild or moderate dementia and pilot-test this toolkit for feasibility and acceptability. Patients with mild to moderate dementia will be recruited for the pilot study in the six participating countries. The study population includes all types of dementia without stratification, as the aim of the study is to construct a digital assessment and intervention toolkit for clinical practice in any patient with cognitive impairment from any type of dementia. Even though the final assessment and intervention toolkit could also be useful for patients with advanced dementia and more severe cognitive impairment, the pilot study will recruit only patients with mild or moderate dementia, who will still be able to provide informed consent, and who will be able to self-assess at least minimum patient-related outcome or patient-related experience measures to validate the behavioural and observational scales and biomarkers used in the toolkit. Patients with dementia treated in the participating study centers will be screened for inclusion criteria and, if suitable will be invited to participate. The study will be performed for seven days, with optional extension to 30 days according to patients' preferences. Patients with baseline data and at least one intervention performed from the digital toolkit and data completed before and after that intervention will be included in the evaluation.
研究者
Lukas Radbruch
Director Department of Palliative Medicine, University Hospital Bonn
University Hospital, Bonn
入排标准
入选标准
- •Mild to moderate dementia of any type
- •Montrea Cognitive Assessment (MoCA) score of 16-25
- •Living at home, or in residential or nursing home care
- •Receiving adequate social support
排除标准
- •Moderate/severe cognitive impairment (MoCA \< 16)
- •No cognitive impairment (MoCA \>25)
- •Inpatient or acute hospital treatment
- •Infectious diseases or lokal skin conditons preventing the use of wearable body sensors
研究组 & 干预措施
Digital Toolkit for assessment of pain and distress
A digital toolkit will be developed using facial emotional recognition and other instruments as well as questionnaires for the assessment of pain and distress in patients with dementia.
干预措施: Digital toolkit for assessment
结局指标
主要结局
Feasibility and acceptability of toolkit
时间窗: 7 days
Patient feedback on feasibility, usefulness and burden of toolkit
Accuracy of toolkit assessments
时间窗: 7 days
Comparison of toolkit assessments of pain and distress (including facial emotional recognition from weekly diary recordings) and PROM/PREM.
次要结局
- Effect of pain/distress interventions(7 days)
- Exploration of specific linguistics and behavioural markers(Baseline, once per intervention week (at the end of the week))
- Technology usability and usage metrics(At the end of intervention)
- Feedback on the diary interface(At the end of intervention)