AI4HOPE Dementia Care Planning Pilot Study 2 ( AI4HOPE2)

Dementia Clinical Trial

— AI4HOPE-P2  

Official title:

AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose, and Endurance in Palliative Care Ofr Dementia: Pilot Study 2 Digital Dementia Care Planning

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292143
• Other study ID #: EU101136769-CLIN2
• 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: +4915158233747
• Email: lukas.radbruch[@]ukbonn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will test a digital care planning decision support system for patients with dementia.

Description:

he 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.

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 month

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Advance Care Planning Toolkit
Participants or their caregivers will access the digital platform for advance care planning

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn

Sponsors (6)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of use of digital platform	acceptability of content included in the platform for ACP across multiple intended end users (patients, carers, and health professionals), acceptability of the platform in the opinion of key stakeholders (e.g. health care commissioners and providers, advocacy groups, etc)	90 days
Primary	Effect of digital platform on documentation of advance care planning	rating of benefit by key stakeholders (e.g. health care commissioners and providers, advocacy groups, etc)	90 days