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| Name | Class |
|---|---|
| University College Cork | OTHER |
| University of Leeds | OTHER |
| Fundacion Intras | UNKNOWN |
| Universidade do Porto |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Toolkit for assessment of pain and distress | Other | A digital toolkit will be developed using facial emotional recognition and other instruments as well as questionnaires for the assessment of pain and distress in patients with dementia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital toolkit for assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and acceptability of toolkit | Patient feedback on feasibility, usefulness and burden of toolkit | 7 days |
| Accuracy of toolkit assessments | Comparison of toolkit assessments of pain and distress (including facial emotional recognition from weekly diary recordings) and PROM/PREM. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of pain/distress interventions | Comparison of before/after assessments of interventions to alleviate pain or distress using the digital toolkit. | 7 days |
| Exploration of specific linguistics and behavioural markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukas Radbruch, MD | Contact | +4922828713495 | lukas.radbruch@ukbonn.de | |
| Holger Brunsch, Dr. | Contact | +49 228 287 10309 | holger.brunsch@ukbonn.de |
| Name | Affiliation | Role |
|---|---|---|
| Lukas Radbruch, MD | Department of Palliative Medicine, University Hospital Bonn | Principal Investigator |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| OTHER |
| University Medical Centre Maribor | OTHER |
Feasibility study
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Exploration of specific linguistics and behavioural markers and their correlation with clinical assess-ment tools' scores.
| Baseline, once per intervention week (at the end of the week) |
| Technology usability and usage metrics | PROM/PREM completion rates, user engagement patterns, and dropout analysis. | At the end of intervention |
| Feedback on the diary interface | Feedback on the diary interface and user experience that could inform future iterations. | At the end of intervention |
| D001523 | Mental Disorders |