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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05418296
Recruitment Status : Enrolling by invitation
First Posted : June 14, 2022
Last Update Posted : September 14, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
mandy, Mentia DTx

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Neurodegenerative Diseases Device: A novel digital health device Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 9, 2022
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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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
A videogame-generated virtual world designed for the AD/ADRD care dyad.


Outcome Measures
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Primary Outcome Measures :
  1. Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- severe) [ Time Frame: 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.


  2. Dementia Quality of Life - Care Home (DemQol-CH) [ Time Frame: 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.


  3. The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The minimum and maximum values are A higher score means a better or worse outcome. [ Time Frame: 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 :
  1. Approaches to Dementia Questionnaire (ADQ) [ Time Frame: 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.


  2. Sense of Competence in Dementia Care Staff (SCIDS) scale [ Time Frame: 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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05418296


Locations
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United States, California
Elder Ashram
Oakland, California, United States, 94602
United States, Illinois
Northbrook Inn
Northbrook, Illinois, United States, 60062
Sponsors and Collaborators
Mentia DTx
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Mandy Salomon, PhD Mentia DTx
More Information
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Additional Information:

Publications:

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Responsible Party: mandy, CEO, Mentia DTx
ClinicalTrials.gov Identifier: NCT05418296    
Other Study ID Numbers: R43AG071102 ( U.S. NIH Grant/Contract )
1R43AG071102-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by mandy, Mentia DTx:
technology
dementia
Alzheimer's disease
virtual
behavioral
cognitive
 immersive
caregiver
digital health
videogame
memory
non-pharmacological
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders