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DementiaNCT05418296

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

A study testing A novel digital health device in people with Dementia and Alzheimer Disease, run by mandy at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 110 years
What is being tested?
A novel digital health device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
2 sitesUnited States
Study dates
9 Jun 2022to 30 Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 110 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Bruceville Point Senior Living Community

    Elk Grove, California, 95757

  • Elder Ashram

    Oakland, California, 94602

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
A novel digital health device
Keywords
technology, dementia, Alzheimer's disease, virtual, behavioral, cognitive, immersive, caregiver, digital health, videogame, memory, non-pharmacological
Medical subject headings
Dementia, Alzheimer Disease, Neurodegenerative Diseases, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A novel digital health deviceDevice

    Also called DevaWorld

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

Study groups in NCT05418296
Study groupRoleWhat they receive
Persons residing in long-term care homesExperimentalSubjects' ADLs are studied with intervention compared to baseline (without intervention).
Receives: Device: A novel digital health device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. The Copenhagen Burnout Index

    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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start9 Jun 2022
  3. Primary completion30 Aug 2023
  4. Study completion30 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
A Virtual Game Environment as a Behavioral Intervention for Alzheimer Disease
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418296
Sponsor's protocol ID
R43AG071102
Other IDs
1R43AG071102-01A1
Status last verified
Jan 2025
First submitted
31 May 2022
Last updated
10 Feb 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 34140328

  • 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.

    PubMed 24635843

  • 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.

    PubMed 26728933

Questions about this trial

What is this clinical trial studying?

A study testing A novel digital health device in people with Dementia and Alzheimer Disease, run by mandy at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05418296, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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Clinical Trial NCT05418296 | AzTrials