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

January 17, 2025 updated by: mandy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Elk Grove, California, United States, 95757
        • Bruceville Point Senior Living Community
      • Oakland, California, United States, 94602
        • Elder Ashram

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 110 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other Names:
  • DevaWorld

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe)
Time Frame: 6 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.
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.
Time Frame: 6 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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Approaches to Dementia Questionnaire (ADQ)
Time Frame: 6 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.
6 weeks
Sense of Competence in Dementia Care Staff (SCIDS) Scale
Time Frame: 6 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.
6 weeks
The Copenhagen Burnout Index
Time Frame: 6 weeks

The Copenhagen Burnout Inventory (CBI) is a 19-item survey that measures burnout in three areas: personal, work-related, and client-related.

Scale ranges from 0 to 300, with high scores indicating high levels of burnout. This inventory is self-administered
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

mandy

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Mandy Salomon, PhD, Mentia DTx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R43AG071102 (U.S. NIH Grant/Contract)
  • 1R43AG071102-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurodegenerative Diseases

Clinical Trials on A novel digital health device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe