Assessing a Novel Virtual Environment That Assists With Activities of Daily Living
Dementia · Alzheimer Disease · Neurodegenerative Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05418296 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- A novel digital health device (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- mandy
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe) |
19.1 | <0.46 |
| PRIMARY The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The Minimum and Maximum Values Are A Higher Score Means a Better or Worse Outcome. |
12.2 | <0.00314 sig |
| SECONDARY Approaches to Dementia Questionnaire (ADQ) |
63.3 | <0.066 |
| SECONDARY Sense of Competence in Dementia Care Staff (SCIDS) Scale |
45.75 | <0.0850 |
| SECONDARY The Copenhagen Burnout Index |
51.5 | <0.0716 |
Summary
Eligibility Criteria
Inclusion Criteria
The subject will have a diagnosis of AD/ADRD, or symptoms of an undiagnosed AD/ADRD as observed by professional care staff and confirmed by the head of clinical care. The investigators will neither include nor exclude participation based on cognitive test scores. The subject will have had challenge(s) completing one or more ADLs in the previous month, as discussed at staff meetings, referenced in care plans, or observed/experienced by direct care staff.
Other specifications:
- Understand English or Russian.
- Can sit comfortably for at least 15 minutes in a chair/wheelchair at a table or propped up in bed or princess chair with a tray table
- Are not known to be in pain
- Have good vision, or good corrected vision (i.e., glasses)
- Have good hearing, or good corrected hearing (i.e., aids)
- May sometimes have anxiety or agitation when undertaking ADLs.
Exclusion Criteria
Ineligible subjects are those with significant non-AD/ADRD neurological, psychiatric, or physical impairment or those who are totally dependent upon others for ADLs.
Data sourced from ClinicalTrials.gov (NCT05418296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.