AI4HOPE Pilot Study 2 Digital Dementia Care Planning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Advance Care Planning Toolkit.
- Who it may be relevant to
- Registry conditions: Dementia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose, and Endurance in Palliative Care Ofr Dementia: Pilot Study 2 Digital Dementia Care Planning
Overview
This pilot study will test a digital care planning decision support system for patients with dementia.
Detailed 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.
Interventions
- Other Advance Care Planning Toolkit
Participants or their caregivers will access the digital platform for advance care planning
Primary outcome measures
- Feasibility and acceptability of digital ACP-platform, the Dementia Journey Companion (DJC) [Time frame: 30 days]
Secondary outcome measures (3)
- Effect of DJC on documentation of ACP [Time frame: 30 days]
- Completion rate of preference documentation [Time frame: 30 days]
- Assessment of pain, distress and anxiety [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06292143 · EU101136769-CLIN2