AI4HOPE Dementia Pain Assessment Pilot Study 1

Dementia Clinical Trial

— AI4HOPE1  

Official title:

AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose and Endurance in Palliative Care for Dementia: Pilot Study 1 Digital Toolkit Assessment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289322
• Other study ID #: EU101136769-CLIN1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2025
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: University of Bonn
• Contact: Lukas Radbruch, MD
• Phone: +4922828713495
• Email: lukas.radbruch[@]ukbonn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Mild or moderate dementia of any type

• Able to provide informed consent, or consent from surrogate decision maker

• Able to self-assess patient-related outcome (PROM) or experience (PREM) measures

Exclusion Criteria:

• Ongoing delir

• Severe cognitive impairment (MMSE < 10 [22])

• Unable to provide informed consent

• Life expectancy estimated less than 3 months

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University of Bonn	Fundacion Intras, Universidade do Porto, University College Cork, University Medical Centre Maribor, University of Leeds

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of toolkit	patient feedback on feasibility, usefulness and burden of toolkit	7 days
Primary	Accuracy of toolkit assessments	comparison of toolkit assessments of pain and distress (including facial emotional recognition) and PROM/PREM	7 days
Secondary	Effect of pain /distress interventions	comparison of before/after assessments of interventions to alleviate pain or distress using the digital toolkit	7 days