Clinical trial NCT05418296: Assessing a Novel Virtual Environment That Assists With Activities of Daily Living
Official title: Assessing a Novel Virtual Environment That Primes Individuals Living With AD/ADRD to Accomplish Activities of Daily Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Neurodegenerative Diseases
Keywords: technology
dementia
Alzheimer's disease
virtual
behavioral
cognitive
immersive
caregiver
digital health
videogame
memory
non-pharmacological
Lead sponsor: Mentia DTx
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-06-14
Enrollment: 38
Sex: ALL
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Virtual Game Environment as a Behavioral Intervention for Alzheimer Disease
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Central themes in person-centered care are dignity/respect/choice for the care recipient.

This Phase l clinical study is a minimal risk study that focuses on how the new technology can support and amplify these principles, while assisting care staff.

The investigators will use a novel digital health device developed with user-centered design principles, mirroring a range of evidence-based non-pharmacological interventions for people living with Alzheimer's disease and its related dementias (AD/ADRD). This is a purpose-built virtual world depicting activities of daily living (ADLs). It contains interactive engagement stimuli, including customized digital artifacts that hold meaning to the person.

The investigators hypothesize that undertaking ADL-related virtual activities will support completions of actual ADLs, thereby increasing effectiveness and improving care outcomes.

Aim 1: Feasibility Successful outcomes are \>55% participation rate and a statistically significant difference between assessments of participation and non-participation, indicating tolerability and acceptability of routine interventions.

Aim 2: Effectiveness

Successful outcomes are:

* a reduction in ADL-related care challenges compared to baseline
* reduced time spent on the evening ADLs compared to baseline
* a reduction in negative response behaviors associated with the ADL
* greater interest in the ADL
* a positive shift in care staff attitudes

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.

Primary outcomes:
measure: Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe)
timeFrame: 6 weeks
measure: The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The Minimum and Maximum Values Are A Higher Score Means a Better or Worse Outcome.
timeFrame: 6 weeks
Secondary outcomes:
measure: Approaches to Dementia Questionnaire (ADQ)
timeFrame: 6 weeks
measure: Sense of Competence in Dementia Care Staff (SCIDS) Scale
timeFrame: 6 weeks
measure: The Copenhagen Burnout Index
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Elk Grove
country: United States
facility: Bruceville Point Senior Living Community
state: California
city: Oakland
country: United States
facility: Elder Ashram
state: California
Study officials:
affiliation: Mentia DTx
name: Mandy Salomon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.