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

Sponsor

Mentia DTx (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05418296

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Locations

Arm

3.7

Anticipated Duration (Months)

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 1 study looks at how a new technology-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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Alzheimer Disease Neurodegenerative Diseases	Device: A novel digital health device	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Assessing a Novel Virtual Environment That Primes Individuals Living With AD/ADRD to Accomplish Activities of Daily Living.

Actual Study Start Date :

Jun 9, 2022

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Persons residing in long-term care homes Subjects' ADLs are studied with intervention compared to baseline (without intervention).	Device: A novel digital health device An immersive virtual world designed for the AD/ADRD care dyad.

Arm

Intervention/Treatment

Experimental: Persons residing in long-term care homes

Subjects' ADLs are studied with intervention compared to baseline (without intervention).

Device: A novel digital health device

An immersive virtual world designed for the AD/ADRD care dyad.

Outcome Measures

Primary Outcome Measures

Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- severe) [8 weeks]
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.
Dementia Quality of Life - Care Home (DemQol-CH) [8 weeks]
A two-factor structure of 'functioning' and 'emotion' organized over three sections that ask about Subjects' feelings, memory and everyday life. There are 31 questions. The minimum and maximum values are 1-4 A higher score means a better health-related-quality-of-life (HRQL) outcome.
The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The minimum and maximum values are A higher score means a better or worse outcome. [8 weeks]
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.

Secondary Outcome Measures

Approaches to Dementia Questionnaire (ADQ) [8 weeks]
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.
Sense of Competence in Dementia Care Staff (SCIDS) scale [8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 110 Years

Sexes Eligible for Study:

All

Accepts 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:

Ineligible subjects are those with significant non-AD/ADRD neurological, psychiatric, or physical impairment or those who are totally dependent upon others for ADLs.