AI4HOPE Pilot Study 2 Digital Dementia Care Planning

NCT06292143 | Not Yet Recruiting

• 1 other identifier: EU101136769-CLIN2
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of DJC on documentation of ACP

  30 days

• Completion rate of preference documentation

  30 days

• Assessment of pain, distress and anxiety

  30 days

Study Arms (1)

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.

Other: Advance Care Planning Toolkit

Interventions

Advance Care Planning Toolkit OTHER

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

Advance Care Planning toolkit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bonn: lead
• University College Cork: collaborator
• University of Leeds: collaborator
• Fundacion Intras: collaborator
• Universidade do Porto: collaborator
• University Medical Centre Maribor: collaborator

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lukas Radbruch, MD

  Department of Palliative Medicine, University Hospital Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Radbruch, MD

CONTACT

+4915158233747; lukas.radbruch@ukbonn.de

Holger Brunsch, Dr.

CONTACT

+49 228 287 10309; holger.brunsch@ukbonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Department of Palliative Medicine, University Hospital Bonn

Model Details: Feasibility study

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 4, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share