NCT05418296

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: mandy · Industry
• Sex: All
• Age: 110 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dementia
• Alzheimer Disease
• Neurodegenerative Diseases

Interventions

Type	Name	Description
DEVICE	A novel digital health device	A videogame-generated virtual world designed for the AD/ADRD care dyad.

Timeline

• Start date: 2022-06-09
• Primary completion: 2023-08-30
• Completion: 2023-10-30
• First posted: 2022-06-14
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study