AI4HOPE Pilot Study 2 Digital Dementia Care Planning

NCT ID: NCT06292143

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-12-31

Brief Summary

This pilot study will test a digital care planning decision support system for patients with dementia.

Detailed Description

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.

Patients with baseline data and at least one interaction with the digital platform and data completed before and after that interaction will be included in the evaluation.

Conditions

Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Advance Care Planning toolkit

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.

Group Type: OTHER

Advance Care Planning Toolkit

Intervention Type: OTHER

Participants or their caregivers will access the digital platform for advance care planning

Interventions

Advance Care Planning Toolkit

Participants or their caregivers will access the digital platform for advance care planning

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Cork

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: collaborator

Fundacion Intras

UNKNOWN

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: collaborator

University Medical Centre Maribor

OTHER

Sponsor Role: collaborator

University of Bonn

OTHER

Sponsor Role: lead

Responsible Party

Lukas Radbruch

Director Department of Palliative Medicine, University Hospital Bonn

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukas Radbruch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Palliative Medicine, University Hospital Bonn

Central Contacts

Lukas Radbruch, MD

Role: CONTACT

lukas.radbruch@ukbonn.de

+4915158233747

Holger Brunsch, Dr.

Role: CONTACT

holger.brunsch@ukbonn.de

+49 228 287 10309

Other Identifiers

EU101136769-CLIN2

Identifier Type: -

Identifier Source: org_study_id