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

NCT05418296 | Completed Results FDA Device

• 2 other identifiers: R43AG0711021R43AG071102-01A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Dementia; Alzheimer Disease; Neurodegenerative Diseases

Keywords

technology; dementia; Alzheimer's disease; virtual; behavioral; cognitive; immersive; caregiver; digital health; videogame; memory; non-pharmacological

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• 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.

  6 weeks

Secondary Outcomes (3)

• Approaches to Dementia Questionnaire (ADQ)

  6 weeks

• Sense of Competence in Dementia Care Staff (SCIDS) Scale

  6 weeks

• The Copenhagen Burnout Index

  6 weeks

Study Arms (1)

Persons residing in long-term care homes

EXPERIMENTAL

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

Device: A novel digital health device

Interventions

A novel digital health device DEVICE

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

Also known as: DevaWorld

Persons residing in long-term care homes

Eligibility Criteria

• Age: Up to 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• mandy: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Bruceville Point Senior Living Community

Elk Grove, California, 95757, United States

Location

Elder Ashram

Oakland, California, 94602, United States

Location

Related Publications (3)

• 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.

  PMID: 34140328 BACKGROUND

• 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.

  PMID: 24635843 BACKGROUND

• 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.

  PMID: 26728933 BACKGROUND

Related Links

• Database of best dementia care resources

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Neurodegenerative Diseases; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies

Limitations and Caveats

Length of study reduced from 8 to 6 weeks due to staff participants' lack of adherence. Reasons: roster changes and absenteeism.

Results Point of Contact

• Title: Dr Mandy Salomon
• Organization: Mentia

mandy@mentia.me

4156326872

Study Officials

• Mandy Salomon, PhD

  Mentia DTx

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Scientific Officer

Model Details: A Virtual Game Environment as a Behavioral Intervention for Alzheimer Disease

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 14, 2022
• Study Start: June 9, 2022
• Primary Completion: August 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)