Assessing a Novel Virtual Environment That Assists With Activities of Daily Living
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|ClinicalTrials.gov Identifier: NCT05418296|
Recruitment Status : Enrolling by invitation
First Posted : June 14, 2022
Last Update Posted : September 14, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease Neurodegenerative Diseases||Device: A novel digital health device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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.
|Ages Eligible for Study:||up to 110 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
Ineligible subjects are those with significant non-AD/ADRD neurological, psychiatric, or physical impairment or those who are totally dependent upon others for ADLs.
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
|United States, California|
|Oakland, California, United States, 94602|
|United States, Illinois|
|Northbrook, Illinois, United States, 60062|
|Principal Investigator:||Mandy Salomon, PhD||Mentia DTx|
|Responsible Party:||mandy, CEO, Mentia DTx|
|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|
|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|
Central Nervous System Diseases
Nervous System Diseases