AI4HOPE Pilot Study 2 Digital Dementia Care Planning (AI4HOPE2)

University of Bonn

Status: Not yet enrolling

Conditions: Dementia

Treatments: Other: Advance Care Planning Toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT06292143

EU101136769-CLIN2

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild or moderate dementia of any type
• Montreal 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 conditions preventing the use of wearable body sensors

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Advance Care Planning toolkit

Other group

Description:

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.

Treatment:

Other: Advance Care Planning Toolkit