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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05418296
• Other study ID #: R43AG071102
• Secondary ID: 1R43AG071102-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: October 2023
• Source: Mentia DTx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 51
• Est. completion date: October 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Neurodegenerative Diseases

Intervention

Device:
• A novel digital health device
A videogame-generated virtual world designed for the AD/ADRD care dyad.

Locations

Country	Name	City	State
United States	Bruceville Point Senior Living Community	Elk Grove	California
United States	Elder Ashram	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Mentia DTx	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks

External Links

•   Database of best dementia care resources