Alzheimer Disease Clinical Trial
Official title:
Assessing a Novel Virtual Environment That Primes Individuals Living With AD/ADRD to Accomplish Activities of Daily Living
Verified date | May 2024 |
Source | Mentia DTx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase 1 study looks at how a new videogame-based program can help residents and care partners prepare for ADLs in a fun way with minimal risk, potentially reducing escalating problems associated with ADL completions.
Status | Completed |
Enrollment | 28 |
Est. completion date | October 30, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 110 Years |
Eligibility | 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: Ineligible subjects are those with significant non-AD/ADRD neurological, psychiatric, or physical impairment or those who are totally dependent upon others for ADLs. |
Country | Name | City | State |
---|---|---|---|
United States | Bruceville Point Senior Living Community | Elk Grove | California |
United States | Elder Ashram | Oakland | California |
Lead Sponsor | Collaborator |
---|---|
Mentia DTx | National Institute on Aging (NIA) |
United States,
Bourgeois J, Laye M, Lemaire J, Leone E, Deudon A, Darmon N, Giaume C, Lafont V, Brinck-Jensen S, Dechamps A, Konig A, Robert P. Relearning of Activities of Daily Living: A Comparison of the Effectiveness of Three Learning Methods in Patients with Dementia of the Alzheimer Type. J Nutr Health Aging. 2016 Jan;20(1):48-55. doi: 10.1007/s12603-016-0675-4. — View Citation
Kahle-Wrobleski K, Coley N, Lepage B, Cantet C, Vellas B, Andrieu S; Plasa DSA Group. Understanding the complexities of functional ability in Alzheimer's disease: more than just basic and instrumental factors. Curr Alzheimer Res. 2014 May;11(4):357-66. doi: 10.2174/1567205011666140317101419. — View Citation
Quail Z, Bolton L, Massey K. Digital delivery of non-pharmacological intervention programmes for people living with dementia during the COVID-19 pandemic. BMJ Case Rep. 2021 Jun 17;14(6):e242550. doi: 10.1136/bcr-2021-242550. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- severe) | The ADCS-ADL assesses the competence of patients with Alzheimer's Disease (AD) in basic and instrumental activities of daily living (ADLs). It can be completed by a caregiver in questionnaire format, or administered by a clinician/researcher as a structured interview with a caregiver.
There are 19 questions. The minimum and maximum values are 0 - 54. A higher score means a better outcome. |
8 weeks | |
Primary | The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The minimum and maximum values are A higher score means a better or worse outcome. | The NPI-NH The NPI-NH has been used to characterize the psychopathology of patients in nursing homes as well as to measure the impact of anti dementia and psychotropic drugs and behavioral changes in dementia patients dwelling in nursing homes.
There are questions. The minimum and maximum values are 12 - 120 A lower score means a better outcome. |
8 weeks | |
Secondary | Approaches to Dementia Questionnaire (ADQ) | The ADQ is a validated questionnaire that aims to assess participants' attitudes towards dementia, and has been shown to be reliable, easy to administer and to score. The ADQ is a 19-item survey that assesses attitudes towards people living with dementia using a five-point Likert scale ranging from 'strongly agree' to 'strongly disagree'.
The total ADQ score ranges from 19 to 95, with higher scores reflecting more positive attitudes towards people living with dementia. |
8 weeks | |
Secondary | Sense of Competence in Dementia Care Staff (SCIDS) scale | The SCIDS scale provides a useful and user-friendly means of measuring sense of competence in care staff.
There are questions. The minimum and maximum values are 17 - 68 A higher score means a better outcome. |
8 weeks |
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