The BRAIN App (Phase 2 SBIR)

NCT06298474 | Recruiting

• 1 other identifier: 2R44AG071105-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Alzheimer Disease; Vascular Dementia

Outcome Measures

Primary Outcomes (4)

• Menorah Park Engagement Scale (MPES)

  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.

  Baseline, that is, Weeks 1 - 4

• Menorah Park Engagement Scale (MPES)

  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.

  Intervention Period, that is, Weeks 5-16

• Engagement for Persons with Dementia Scale (EPWDS)

  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.

  Baseline, that is, Weeks 1 - 4

• Engagement for Persons with Dementia Scale (EPWDS)

  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.

  Baseline, that is, Weeks 5-16

Secondary Outcomes (8)

• Dementia Related Quality of Life (DEMQOL)

  Baseline, that is, Weeks 1 - 4

• Dementia Related Quality of Life (DEMQOL)

  Post-Intervention, that is, Weeks 17-18

• Neuropsychiatric Inventory--Nursing Home (NPI-NH)

  Baseline, that is, Weeks 1 - 4

• Neuropsychiatric Inventory--Nursing Home (NPI-NH)

  Post-Intervention, that is, Weeks 17-18

• Quality of Carer-Patient Relationship (QCPR)

  Baseline, that is, Weeks 1 - 4

Study Arms (2)

Experimental, BRAIN Programming

EXPERIMENTAL

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.

Behavioral: The BRAIN App

Control: Standard Programming / Care

NO INTERVENTION

PLWD in the Control Group will participate in standard care / programming for 3 months.

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.

Experimental, BRAIN Programming

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• + years old
• Clinical diagnosis of dementia (any type)
• Able to speak conversational English

You may not qualify if:

• Completely unable to communicate verbally
• Serious visual or hearing impairments
• Signs of rapid decline over the last three months (based upon staff report)

Sponsors & Collaborators

• Hopeful Aging: lead

Study Sites (1)

Hopeful Aging

Winchester, Massachusetts, 01890, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Cluster Randomized Trial (CRT) will be conducted with each LTC facility being considered a cluster. All PLWD at an Experimental facility will be invited to use the intervention twice per week for 3 months, while all PLWD at a Control facility will receive standard care/programming for 3 months. Individual random assignment is not feasible, due to the high likelihood of contamination in a study involving the facilitation of activities in a LTC environment. LTC Facilities Eight (8) LTC facilities will participate in the study-i.e., 4 NHs and 4 ALFs. Half of the sites will be randomly assigned to the Experimental Group and the other half to the Control Group. So, 2 NHs and 2 ALFs will be assigned to the Experimental Group, while 2 NHs and 2 ALFs will be assigned to the Control Group.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (1)