Assessing a Novel Virtual Environment That Assists With Activities of Daily Living

mandy

Status

Completed

Conditions

Alzheimer Disease

Neurodegenerative Diseases

Dementia

Treatments

Device: A novel digital health device

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT05418296

1R43AG071102-01A1 (U.S. NIH Grant/Contract)

R43AG071102

Details and patient eligibility

About

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.

Full 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

Enrollment

38 patients

Sex

All

Ages

Under 110 years old

Volunteers

No Healthy Volunteers

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.