AI4HOPE Pilot Study 1 Digital Toolkit Assessment
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: Digital toolkit for assessment.
- 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 for Dementia: Pilot Study 1 Digital Toolkit Assessment
Overview
The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired 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 fo assessment and monitoring of patients with mild or moderate dementia and pilot-test this toolkit for feasibility and acceptability.
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 construct a digital assessment and intervention toolkit for clinical practice in any patient with cognitive impairment from any type of dementia.
Even though the final assessment and intervention toolkit could also be useful for patients with advanced dementia and more severe cognitive impairment, 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 at least minimum patient-related outcome or patient-related experience measures to validate the behavioural and observational scales and biomarkers used in the toolkit.
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 seven days, with optional extension to 30 days according to patients' preferences.
Patients with baseline data and at least one intervention performed from the digital toolkit and data completed before and after that intervention will be included in the evaluation.
Interventions
- Other Digital toolkit for assessment
The pilot study uses a digital assessment and intervention toolkit. The person with dementia and caregivers may choose from the digital interventions offered in the toolbox without any mandatory conditions.
Primary outcome measures
- Feasibility and acceptability of toolkit [Time frame: 7 days]
- Accuracy of toolkit assessments [Time frame: 7 days]
Secondary outcome measures (4)
- Effect of pain/distress interventions [Time frame: 7 days]
- Exploration of specific linguistics and behavioural markers [Time frame: Baseline, once per intervention week (at the end of the week)]
- Technology usability and usage metrics [Time frame: At the end of intervention]
- Feedback on the diary interface [Time frame: At the end of intervention]
Eligibility criteria
Inclusion criteria
- Mild to moderate dementia of any type
- Montrea 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 conditons 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: NCT06289322 · EU101136769-CLIN1