AI4HOPE Dementia Care Planning Pilot Study 2 ( AI4HOPE2)

Not Applicable

Not yet recruiting

• Conditions: Dementia
• Interventions: Other: Advance Care Planning Toolkit

• Registration Number: NCT06292143
• Lead Sponsor: University of Bonn

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Study Start: 2025-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Advance Care Planning toolkit	Advance Care Planning Toolkit	Provision of access to the digital ACP (Advance Care Planning) platform to patients and caregivers, baseline assessment with the ACP digital platform on day 0. Information to guide decision making around care and treatment preferences are accessed by patients and carers on days 1 to 7. Where desired, care and treatment preferences are recorded. Evaluation of usefulness and burden of the digital platform for ACP on day 7. Content stored on digital platform for ACP shared across care settings to those involved in care of participant on day 8 to 29. Evaluation of usefulness and burden of the digital platform for ACP, participant and carer experience of completion. Initial exploration of impact on communication between health and social care professionals, access to timely information to inform clinical decision making, and efficiency savings (e.g. reduction in paper forms and duplication, less time chasing information) on day 90.

Primary Outcome Measures

Name	Time	Method
Ease of use of digital platform	90 days	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)
Effect of digital platform on documentation of advance care planning	90 days	rating of benefit by key stakeholders (e.g. health care commissioners and providers, advocacy groups, etc)

Trial Locations

Locations (1)

University Hospital Bonn; 🇩🇪 Bonn, Germany