AI4HOPE Pilot Study 1 Digital Toolkit Assessment

NCT ID: NCT06289322

Last Updated: 2026-02-05

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: 2026-12-31

Brief 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.

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

Study Design

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

Study Groups

Digital Toolkit for assessment of pain and distress

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.

Group Type: OTHER

Digital toolkit for assessment

Intervention Type: OTHER

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.

Interventions

Digital toolkit for assessment

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• 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

+4922828713495

Holger Brunsch, Dr.

Role: CONTACT

holger.brunsch@ukbonn.de

+49 228 287 10309

Other Identifiers

EU101136769-CLIN1

Identifier Type: -

Identifier Source: org_study_id