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

Primary Purpose

Dementia, Alzheimer Disease, Neurodegenerative Diseases

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A novel digital health device
Sponsored by
Mentia DTx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring technology, dementia, Alzheimer's disease, virtual, behavioral, cognitive, immersive, caregiver, digital health, videogame, memory, non-pharmacological

Eligibility Criteria

undefined - 110 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Bruceville Point Senior Living Community
  • Elder Ashram

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Persons residing in long-term care homes

Arm Description

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

Outcomes

Primary Outcome Measures

Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- severe)
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)
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.
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)
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
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.

Full Information

First Posted
May 31, 2022
Last Updated
October 3, 2023
Sponsor
Mentia DTx
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05418296
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mentia DTx
Collaborators
National Institute on Aging (NIA)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Neurodegenerative Diseases
Keywords
technology, dementia, Alzheimer's disease, virtual, behavioral, cognitive, immersive, caregiver, digital health, videogame, memory, non-pharmacological

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Persons residing in long-term care homes
Arm Type
Experimental
Arm Description
Subjects' ADLs are studied with intervention compared to baseline (without intervention).
Intervention Type
Device
Intervention Name(s)
A novel digital health device
Intervention Description
A videogame-generated virtual world designed for the AD/ADRD care dyad.
Primary Outcome Measure Information:
Title
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- severe)
Description
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.
Time Frame
8 weeks
Title
Dementia Quality of Life - Care Home (DemQol-CH)
Description
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.
Time Frame
8 weeks
Title
The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The minimum and maximum values are A higher score means a better or worse outcome.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Approaches to Dementia Questionnaire (ADQ)
Description
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.
Time Frame
8 weeks
Title
Sense of Competence in Dementia Care Staff (SCIDS) scale
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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: Ineligible subjects are those with significant non-AD/ADRD neurological, psychiatric, or physical impairment or those who are totally dependent upon others for ADLs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandy Salomon, PhD
Organizational Affiliation
Mentia DTx
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bruceville Point Senior Living Community
City
Elk Grove
State/Province
California
ZIP/Postal Code
95757
Country
United States
Facility Name
Elder Ashram
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34140328
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.
Results Reference
background
PubMed Identifier
24635843
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.
Results Reference
background
PubMed Identifier
26728933
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.
Results Reference
background
Links:
URL
https://bpc.caregiver.org/
Description
Database of best dementia care resources

Learn more about this trial

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

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