Clinical trial NCT06292143: AI4HOPE Dementia Care Planning Pilot Study 2 ( AI4HOPE2)
Official title: AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose, and Endurance in Palliative Care Ofr Dementia: Pilot Study 2 Digital Dementia Care Planning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: University College Cork
name: University of Leeds
name: Fundacion Intras
name: Universidade do Porto
name: University Medical Centre Maribor
First posted: 2024-03-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ease of use of digital platform
timeFrame: 90 days
measure: Effect of digital platform on documentation of advance care planning
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
affiliation: Department of Palliative Medicine, University Hospital Bonn
name: Lukas Radbruch, MD
role: PRINCIPAL_INVESTIGATOR
References: