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临床试验/NCT06289322
NCT06289322尚未招募不适用

AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose and Endurance in Palliative Care for Dementia: Pilot Study 1 Digital Toolkit Assessment

University of Bonn0 个研究点目标入组 150 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
Feasibility and acceptability of toolkit

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

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

Other

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 (Other)

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lukas Radbruch

Director Department of Palliative Medicine, University Hospital Bonn

University Hospital, Bonn

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