DementiaAI4HOPE1NCT06289322
AI4HOPE Pilot Study 1 Digital Toolkit Assessment
A study testing Digital toolkit for assessment in people with Dementia, run by University of Bonn.
Trial summary
The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Digital toolkit for assessment
- 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 2026
- 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 to moderate dementia of any type
- Montrea 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 conditons 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 for Dementia: Pilot Study 1 Digital Toolkit Assessment
The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired 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 fo assessment and monitoring of patients with mild or moderate dementia and pilot-test this toolkit for feasibility and acceptability.
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 construct a digital assessment and intervention toolkit for clinical practice in any patient with cognitive impairment from any type of dementia.
Even though the final assessment and intervention toolkit could also be useful for patients with advanced dementia and more severe cognitive impairment, 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 at least minimum patient-related outcome or patient-related experience measures to validate the behavioural and observational scales and biomarkers used in the toolkit.
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 seven days, with optional extension to 30 days according to patients' preferences.
Patients with baseline data and at least one intervention performed from the digital toolkit and data completed before and after that intervention will be included in the evaluation.
- Conditions
- Dementia
- Being tested
- Digital toolkit for assessment
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital toolkit for assessmentOther
The pilot study uses a digital assessment and intervention toolkit. The person with dementia and caregivers may choose from the digital interventions offered in the toolbox without any mandatory conditions.
| Study group | Role | What they receive |
|---|---|---|
| Digital Toolkit for assessment of pain and distress | Other | A digital toolkit will be developed using facial emotional recognition and other instruments as well as questionnaires for the assessment of pain and distress in patients with dementia. Receives: Other: Digital toolkit for assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of toolkit
Patient feedback on feasibility, usefulness and burden of toolkit
Measured: 7 days
Accuracy of toolkit assessments
Comparison of toolkit assessments of pain and distress (including facial emotional recognition from weekly diary recordings) and PROM/PREM.
Measured: 7 days
Secondary outcomes (4)
Effect of pain/distress interventions
Comparison of before/after assessments of interventions to alleviate pain or distress using the digital toolkit.
Measured: 7 days
Exploration of specific linguistics and behavioural markers
Exploration of specific linguistics and behavioural markers and their correlation with clinical assess-ment tools' scores.
Measured: Baseline, once per intervention week (at the end of the week)
Technology usability and usage metrics
PROM/PREM completion rates, user engagement patterns, and dropout analysis.
Measured: At the end of intervention
Feedback on the diary interface
Feedback on the diary interface and user experience that could inform future iterations.
Measured: At the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study startFeb 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- NCT06289322
- Sponsor's protocol ID
- EU101136769-CLIN1
- Acronym
- AI4HOPE1
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2024
- Last updated
- 5 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 5 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 for Dementia: Pilot Study 1 Digital Toolkit Assessment
- ClinicalTrials.gov ID
- NCT06289322
- Acronym / sponsor ID
- AI4HOPE1 / EU101136769-CLIN1
- 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
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 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.
The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired 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 fo assessment and monitoring of patients with mild or moderate dementia and pilot-test this toolkit for feasibility and acceptability.
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 construct a digital assessment and intervention toolkit for clinical practice in any patient with cognitive impairment from any type of dementia.
Even though the final assessment and intervention toolkit could also be useful for patients with advanced dementia and more severe cognitive impairment, 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 at least minimum patient-related outcome or patient-related experience measures to validate the behavioural and observational scales and biomarkers used in the toolkit.
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 seven days, with optional extension to 30 days according to patients' preferences.
Patients with baseline data and at least one intervention performed from the digital toolkit and data completed before and after that intervention 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 |
|---|---|---|
| Digital Toolkit for assessment of pain and distress | Other | Other: Digital toolkit for assessmentA digital toolkit will be developed using facial emotional recognition and other instruments as well as questionnaires for the assessment of pain and distress in patients with dementia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to moderate dementia of any type
- Montrea 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 conditons 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 |
|---|---|---|
| Digital toolkit for assessmentThe pilot study uses a digital assessment and intervention toolkit. The person with dementia and caregivers may choose from the digital interventions offered in the toolbox without any mandatory conditions. | Other | Digital Toolkit for assessment of pain and distress |
Primary outcome
Feasibility and acceptability of toolkit
Time frame: 7 days
Patient feedback on feasibility, usefulness and burden of toolkit
Accuracy of toolkit assessments
Time frame: 7 days
Comparison of toolkit assessments of pain and distress (including facial emotional recognition from weekly diary recordings) and PROM/PREM.
4 secondary outcomes
Effect of pain/distress interventions
Time frame: 7 days
Exploration of specific linguistics and behavioural markers
Time frame: Baseline, once per intervention week (at the end of the week)
Technology usability and usage metrics
Time frame: At the end of intervention
Feedback on the diary interface
Time frame: At the end of intervention
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 5 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 Digital toolkit for assessment 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 5 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 (+4922828713495, 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 toolkit (time frame: 7 days). The study lists 2 primary outcomes in all. 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 5 Feb 2026.