Assessing a Novel Virtual Environment That Primes Individuals Living With AD/ADRD to Accomplish Activities of Daily Living
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 110 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Ineligible subjects are those with significant non-AD/ADRD neurological, psychiatric, or physical impairment or those who are totally dependent upon others for ADLs.
结局指标
主要结局
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe)
时间窗: 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.
The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The Minimum and Maximum Values Are A Higher Score Means a Better or Worse Outcome.
时间窗: 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.
次要结局
- The Copenhagen Burnout Index(6 weeks)
- Approaches to Dementia Questionnaire (ADQ)(6 weeks)
- Sense of Competence in Dementia Care Staff (SCIDS) Scale(6 weeks)
研究者
mandy
Chief Scientific Officer
Mentia DTx