AI4HOPE Pilot Study 1 Digital Toolkit Assessment (AI4HOPE1)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia
• Intervention / Treatment: Other: Digital toolkit for assessment

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

Contacts and Locations

• Study Contact: Name: Lukas Radbruch, MD; Phone Number: +4922828713495; Email: lukas.radbruch@ukbonn.de
• Study Contact Backup: Name: Holger Brunsch, Dr.; Phone Number: +49 228 287 10309; Email: holger.brunsch@ukbonn.de

Participation Criteria

Eligibility Criteria

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

Description

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

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: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and acceptability of toolkit	Patient feedback on feasibility, usefulness and burden of toolkit	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of pain/distress interventions	Comparison of before/after assessments of interventions to alleviate pain or distress using the digital toolkit.	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.	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.	At the end of intervention
Feedback on the diary interface	Feedback on the diary interface and user experience that could inform future iterations.	At the end of intervention

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): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 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; Investigative Techniques; Therapeutics; Behavior Control; Immobilization; Restraint, Physical
• Other Study ID Numbers: EU101136769-CLIN1

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