The BRAIN App (Phase 2 SBIR)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHopeful Aging

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

65+ years old

Clinical diagnosis of dementia (any type)

Able to speak conversational English

Disqualifiers

Completely unable to communicate verbally

Serious visual or hearing impairments

Signs of rapid decline over the last three months (based upon staff report)

Trial design

Design model

Parallel

Treatments tested in this trial

  • The BRAIN App

    Behavioral

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental, BRAIN ProgrammingExperimental treatment 1 intervention
Group B: Control: Standard Programming / CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, that is, Weeks 1 - 4
2

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.

Time frame
Intervention Period, that is, Weeks 5-16
3

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.

Time frame
Baseline, that is, Weeks 1 - 4
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.

Time frame
Baseline, that is, Weeks 5-16

Secondary outcomes

1

Dementia Related Quality of Life (DEMQOL)

The DEMQOL measures quality of life, composed of 28 items. Scores range from zero (0) to 112. Higher scores represent better outcomes.

Time frame
Baseline, that is, Weeks 1 - 4
2

Dementia Related Quality of Life (DEMQOL)

The DEMQOL measures quality of life, composed of 28 items. Scores range from zero (0) to 112. Higher scores represent better outcomes.

Time frame
Post-Intervention, that is, Weeks 17-18
3

Neuropsychiatric Inventory--Nursing Home (NPI-NH)

The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency. The total score for F x S ranges from 0 to 120. Lower scores indicate better outcomes.

Time frame
Baseline, that is, Weeks 1 - 4
4

Neuropsychiatric Inventory--Nursing Home (NPI-NH)

The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency. The total score for F x S ranges from 0 to 120. Lower scores indicate better outcomes.

Time frame
Post-Intervention, that is, Weeks 17-18

Other outcomes

Sponsors and contacts

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