AI4HOPE Pilot Study 2 Digital Dementia Care Planning (AI4HOPE2)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia
• Intervention / Treatment: Other: Advance Care Planning Toolkit

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lukas Radbruch, MD; Phone Number: +4915158233747; Email: lukas.radbruch@ukbonn.de
• Study Contact Backup: Name: Holger Brunsch, Dr.; Phone Number: +49 228 287 10309; Email: holger.brunsch@ukbonn.de

Study Locations

• Germany
  • Bonn, Germany, 53127
    • University Hospital Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Other: Advance Care Planning Toolkit; Participants or their caregivers will access the digital platform for advance care planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and acceptability of digital ACP-platform, the Dementia Journey Companion (DJC)	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of DJC on documentation of ACP	Rating of benefit by health care professionals.	30 days
Completion rate of preference documentation	Completion rate of preference documentation across domains (daily living, medical, end-of-life) and frequency of use; frequency of chatbot interactions; number of memories, stories, and preferences documented.	30 days
Assessment of pain, distress and anxiety	Assessment of pain, distress and anxiety (PROM as part of assessment toolkit).	30 days

Collaborators and Investigators

• Sponsor: University of Bonn
• Collaborators: University of Leeds; University College Cork; Universidade do Porto; University Medical Centre Maribor; Fundacion Intras
• Investigators: Principal Investigator: Lukas Radbruch, MD, Department of Palliative Medicine, University Hospital Bonn

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: EU101136769-CLIN2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No