The BRAIN App (Phase 2 SBIR): Building Relationships Using Artificial Intelligence and Nostalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Engagement for Persons with Dementia Scale (EPWDS)
研究概览
简要总结
There are currently 6.7 million Americans living with dementia and, without significant breakthroughs, this figure will double to 12.7 million by 2050. There are about 46,000 long-term care (LTC) facilities in the U.S. More than half of LTC residents have some form of dementia (Alzheimer's Association, 2018). Responsive behaviors and dysfunction of the dementia care triad-i.e., the PLWD, professional Care Partner (CP), and Family Member (FM)-are inexorably linked. The emergence of responsive behaviors can lead to disruption of the triad's function. Thus, it is imperative to maintain positive relationships and a high quality of life (QoL) within the triad to reduce BPSD. Cognitive Stimulation Therapy (CST) has demonstrated improvements in QoL and relationships for PLWD. CST is a psychosocial intervention that promotes communication and engagement in PLWD via a structured program of meaningful and enjoyable theme. While clinical trials have shown improvement in cognition and QoL, the potential large-scale impact of CST has been hampered by low adherence, with less than 40% completing trials. One likely reason for the low adherence to CST is the reliance on generic and non-digital tools (e.g., paper-based agendas, tools, DVDs, and board games) in facilitating the intervention. That is, even though CST aims to be personalized, the specific interventions used in the field tend to be generic and not tailored to each PLWD's specific interests. The use of digital technology to implement CST would offer considerable advantages to expand and personalize the range of stimulation content and provide a means for monitoring responses, optimizing protocols, and promoting adherence.
The proposed Phase II study will involve the continued development and evaluation of a multi-faceted software platform called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN Platform will be the first-ever Artificial Intelligence (AI) powered CST digital therapy platform for PLWD. The platform, which has been shown to be effective in an initial Phase I clinical trial, has three main goals: to improve the quality of life of PLWD, to reduce BPSD in PLWD, and to foster positive relationships between members of the care triad. The proposed Phase II project has the following Specific Aims: 1. Create an improved Beta version of the BRAIN Platform's eight components: (1) the Admin Management Dashboard, (2) the Annotation Dashboard, (3) the Log Viewer, (4) the Content Management System (CMS), (5) the Private CMS, (6) the Control App, (7) the Home App, and (8) the Training Dashboard. 2. Fine-tune the different classes of AI algorithms-i.e., behavioral analytics, personalized content recommendation, and personalized program generation-in the BRAIN app such that they can (a) recognize and track 12 distinct behaviors and indicators of PLWD, (b) use these behavioral traits as a basis for automatically rating the relative success of each activity, and (c) automatically recommend personalized activities that are likely to be successful for individual PLWD. 3. Conduct a Cluster Randomized Trial (CRT) of the BRAIN App to examine the app's impact on engagement/affect, quality of life, and responsive behaviors. 4. Examine satisfaction and ease of use of the app for PLWD, LTC staff, and FMs.
详细描述
Sample Sample PLWD, The primary sample will consist of 120 PLWD-i.e., at each of the 8 LTC facilities, 15 PLWD will participate in the study (8 sites x 15 PLWD = 120 PLWD). Half of the PLWD (n=60) will be in the Experimental Group and the other half (n=60) will be in the Control Group. PLWD will be split equally between NHs and ALFs, so sample sizes will be as follows for each site type/condition: Experimental NH, n=30; Experimental ALF, n=30; Control NH, n=30; Control ALF, n=30. Family Members For each PLWD living at an Experimental Site, one family member will participate in the study. As such, 60 Family Members will participate in the study. Family Members will facilitate the BRAIN intervention twice per month and provide feedback related to satisfaction and ease of use. Staff Members At each Experimental Site, 6 staff members will participate, including 1 administrator/executive director, 1 activity staff member, and 3 CPs. Since there are four Experimental Sites, 24 staff members will participate. Staff members will take the BRAIN Training Modules, use the BRAIN Platform at least twice, and provide feedback related to satisfaction and ease of use. Diversity: As was true in Phase I, we are committed to testing the app with a diverse sample.
Study Design The study will utilize a quasi-experimental pre-post design-i.e., baseline vs. treatment / post-treatment.
Inclusion/Exclusion Criteria Inclusion Criteria: PLWD, 65+ years old, dementia diagnosis (any type), and able to speak conversational English; Family/Staff Members, 18+ years old and able to speak English. (Activity content/questionnaires will be in English).
Exclusion Criteria PLWD, completely unable to communicate verbally, serious visual or hearing impairments, and/or signs of rapid decline over the last three months (based upon staff report); Family/Staff Members, none.
Analyses Primary Outcomes: Engagement/affect, quality of life, and responsive behaviors/BPSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65+ years old
- •Clinical diagnosis of dementia (any type)
- •Able to speak conversational English
排除标准
- •Completely unable to communicate verbally
- •Serious visual or hearing impairments
- •Signs of rapid decline over the last three months (based upon staff report)
研究组 & 干预措施
Experimental, BRAIN Programming
PLWD in the Experimental Group will be invited to use the BRAIN intervention twice per week for 3 months. Each session is expected to last 20-30 minutes. The BRAIN app will initially recommend activities for each PLWD based upon his/her background/interests/preferences, which will be collected when the PLWD first enrolls in the study. After the initial sessions, the BRAIN app will use AI to recommend new activities for subsequent sessions. These recommendations will be based upon the AI's rating of the relative success or failure of the activities initially provided to the PLWD.
干预措施: The BRAIN App (Behavioral)
Control: Standard Programming / Care
PLWD in the Control Group will participate in standard care / programming for 3 months.
结局指标
主要结局
Engagement for Persons with Dementia Scale (EPWDS)
时间窗: Baseline, that is, Weeks 5-16
This scale measures the engagement in 5 domains: affective, visual, verbal, behavioral and social. Scores range from zero (0) to 36 with higher scores indicating a better outcome.
Menorah Park Engagement Scale (MPES)
时间窗: Intervention Period, that is, Weeks 5-16
The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure. Scores on each type of engagement item range from 0 to 2 with higher scores indicating a better outcome for Constructive Engagement, Passive Engagement, and Pleasure. Higher scores represent worse outcomes for Distracted and Non Engagement.
次要结局
- Neuropsychiatric Inventory--Nursing Home (NPI-NH)(Post-Intervention, that is, Weeks 17-18)
- Quality of Carer-Patient Relationship (QCPR)(Post-Intervention, that is, Weeks 17-18)
- Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE)(Post-Intervention, that is, Weeks 17-18)
- Dementia Related Quality of Life (DEMQOL)(Post-Intervention, that is, Weeks 17-18)
