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This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, physiological, and audio data; and eCOA and EMA responses with mobile devices (iPhone, Apple Watch).
The purpose of this study is to evaluate and improve HealthMode Apps data collection and usability in subjects experiencing agitation in the context of dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dementia | Subjects with a diagnosis of dementia who are experiencing agitation severe enough that it interferes with activities of daily living or social interaction. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of passive and continuous data collection | Total time and percentage of continuous data collection for each stream of data aiming for >50% coverage. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of carrying a smartphone and wearing a data collection sensor on the wrist and/or hand in a population of subjects who may have frequent episodes of agitation or impulsive behavior. | Caregiver and Staff engagement with the eCOA and EMA (threshold 80% completion) and responses to usability questionnaires at week 1 and 4 to provide feedback on comfort, usability and engagement. The score ranges from 10 to 50, higher score indicating a better usability. |
| Measure | Description | Time Frame |
|---|---|---|
| Suitability of individual data streams and their combinations for purposes of identification of agitation episodes in passively collected data. | Comparison of data collected from the smartphone and wearable device to episodes identified by subject or caregiver assessment:
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Inclusion Criteria:
Exclusion Criteria:
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Eligible individuals who have a diagnosis of dementia and a recent history of agitation will sign an informed consent, with a legally authorized representative (LAR) when necessary, to enroll in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Neuroscience Research, LLC | Tucson | Arizona | 85710 | United States | ||
| Virtual Research Site |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| D015140 | Dementia, Vascular |
| D057180 | Frontotemporal Dementia |
| D020961 | Lewy Body Disease |
| D000093902 | Mixed Dementias |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| 28 days |
| 28 days |
| New York |
| New York |
| 10001 |
| United States |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D057174 | Frontotemporal Lobar Degeneration |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |