The BRAIN App (Phase 2 SBIR)

Part of paid clinical trials in Winchester, Massachusetts.

Sponsor
Hopeful Aging
Study ID
NCT06298474
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The BRAIN App — BEHAVIORAL
    The BRAIN App is digital engagement platform that uses AI to tailor activities to each person's specific interests / background.

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
Jun 2025
Primary completion
Jun 15, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: Control: Standard Programming / Care
    PLWD in the Control Group will participate in standard care / programming for 3 months.

Primary Outcome Measure

Menorah Park Engagement Scale (MPES) [ Time Frame: Baseline, that is, Weeks 1 - 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hopeful AgingWinchesterMassachusetts01890
Michael Skrajner, MA
[email protected]
440-477-7881

Find similar trials in Winchester, MA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Hopeful Aging· Winchester, MA

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