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临床试验/NCT06292143
NCT06292143尚未招募不适用

AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose, and Endurance in Palliative Care Ofr Dementia: Pilot Study 2 Digital Dementia Care Planning

University of Bonn1 个研究点 分布在 1 个国家目标入组 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
试验地点
1
主要终点
Feasibility and acceptability of digital ACP-platform, the Dementia Journey Companion (DJC)

研究概览

简要总结

This pilot study will test a digital care planning decision support system for 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 for advance care planning and decision making for patients with dementia and pilot-test this digital support system for feasibility and acceptability.

Other workpackages of the AI4HOPE project will design a digital technology platform to provide relevant, timely and appropriate information for people with dementia and their carers, and to facilitate them to document their goals, wishes, and preferences for future care.

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 develop a digital technology platform to facilitate ACP for clinical practice in any patient with cognitive impairment from any type of dementia.

Even though the digital platform could be adapted to be useful for patients with advanced dementia and more severe cognitive impairment, or for use just by their families, 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 for patient-related outcome or patient-related experience measures to inform the assessment of the digital technology platform.

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 up to 90 days, with optional extension to 180 days according to patients' preferences.

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 or moderate dementia of any type
  • Montreal 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 conditions preventing the use of wearable body sensors

研究组 & 干预措施

Advance Care Planning toolkit

Other

Provision of access to the digital ACP (Advance Care Planning) platform to patients and caregivers, baseline assessment with the ACP digital platform on day 0.

Information to guide decision making around care and treatment preferences are accessed by patients and carers on days 1 to 7. Where desired, care and treatment preferences are recorded.

Evaluation of usefulness and burden of the digital platform for ACP on day 7. Content stored on digital platform for ACP shared across care settings to those involved in care of participant on day 8 to 29.

Evaluation of usefulness and burden of the digital platform for ACP, participant and carer experience of completion. Initial exploration of impact on communication between health and social care professionals, access to timely information to inform clinical decision making, and efficiency savings (e.g. reduction in paper forms and duplication, less time chasing information) on day 90.

干预措施: Advance Care Planning Toolkit (Other)

结局指标

主要结局

Feasibility and acceptability of digital ACP-platform, the Dementia Journey Companion (DJC)

时间窗: 30 days

Participant feedback on feasibility, usefulness and burden of ACP-platform; acceptability of content included in the ACP-platform for participantd, user satisfaction with conversational support and suc-cess rate in achieving communicative goals, answering questions and providing guidance.

次要结局

  • Effect of DJC on documentation of ACP(30 days)
  • Completion rate of preference documentation(30 days)
  • Assessment of pain, distress and anxiety(30 days)

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

研究点 (1)

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