Dementia
Conditions
Brief summary
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
OTHERDigital 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.
Sponsors
University of Bonn
University College Cork
University of Leeds
Fundacion Intras
Universidade do Porto
University Medical Centre Maribor
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Feasibility study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and acceptability of toolkit | 7 days | Patient feedback on feasibility, usefulness and burden of toolkit |
| Accuracy of toolkit assessments | 7 days | Comparison of toolkit assessments of pain and distress (including facial emotional recognition from weekly diary recordings) and PROM/PREM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of pain/distress interventions | 7 days | Comparison of before/after assessments of interventions to alleviate pain or distress using the digital toolkit. |
| Exploration of specific linguistics and behavioural markers | Baseline, once per intervention week (at the end of the week) | Exploration of specific linguistics and behavioural markers and their correlation with clinical assess-ment tools' scores. |
| Technology usability and usage metrics | At the end of intervention | PROM/PREM completion rates, user engagement patterns, and dropout analysis. |
| Feedback on the diary interface | At the end of intervention | Feedback on the diary interface and user experience that could inform future iterations. |
Contacts
CONTACTLukas Radbruch, MD
CONTACTHolger Brunsch, Dr.
PRINCIPAL_INVESTIGATORLukas Radbruch, MD
Department of Palliative Medicine, University Hospital Bonn
Outcome results
None listed