DementiaAI4HOPE2NCT06292143
AI4HOPE Pilot Study 2 Digital Dementia Care Planning
A study testing Advance Care Planning Toolkit in people with Dementia, run by University of Bonn.
Trial summary
This pilot study will test a digital care planning decision support system for patients with dementia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Advance Care Planning Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Advance Care Planning Toolkit
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care Planning ToolkitOther
Participants or their caregivers will access the digital platform for advance care planning
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Advance Care Planning Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
Effect of DJC on documentation of ACP
Rating of benefit by health care professionals.
Measured: 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.
Measured: 30 days
Assessment of pain, distress and anxiety
Assessment of pain, distress and anxiety (PROM as part of assessment toolkit).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study startFeb 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, University of Leeds, Fundacion Intras, Universidade do Porto, University Medical Centre Maribor
- Responsible party
- Principal investigator, Lukas Radbruch, University Hospital, Bonn
- Investigators
- Lukas Radbruch, MD, Principal investigator, Department of Palliative Medicine, University Hospital Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292143
- Sponsor's protocol ID
- EU101136769-CLIN2
- Acronym
- AI4HOPE2
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose, and Endurance in Palliative Care Ofr Dementia: Pilot Study 2 Digital Dementia Care Planning
- ClinicalTrials.gov ID
- NCT06292143
- Acronym / sponsor ID
- AI4HOPE2 / EU101136769-CLIN2
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- University College Cork, University of Leeds, Fundacion Intras, Universidade do Porto, University Medical Centre Maribor
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Advance Care Planning toolkit | Other | Other: Advance Care Planning ToolkitProvision 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Care Planning ToolkitParticipants or their caregivers will access the digital platform for advance care planning | Other | Advance Care Planning toolkit |
Primary outcome
Feasibility and acceptability of digital ACP-platform, the Dementia Journey Companion (DJC)
Time frame: 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.
3 secondary outcomes
Effect of DJC on documentation of ACP
Time frame: 30 days
Completion rate of preference documentation
Time frame: 30 days
Assessment of pain, distress and anxiety
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lukas Radbruch, MD principal investigator
Department of Palliative Medicine, University Hospital Bonn
Questions about this trial
What is this clinical trial studying?
A study testing Advance Care Planning Toolkit in people with Dementia, run by University of Bonn.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Radbruch, MD (+4915158233747, lukas.radbruch@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of digital ACP-platform, the Dementia Journey Companion (DJC) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.