The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia

NCT ID: NCT05515679

Last Updated: 2024-03-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2022-12-31

Brief Summary

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This study will involve testing of an Alpha version of an app called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN App will be the first -ever artificial intelligence infused CST app for PWD. The app has two main goals: (1) to foster positive relationships between the care triad, and (2) to promote QoL while reducing responsive behaviors in PWD. Testing will examine the app's impact on engagement/affect for both PWD and professional Care Partners.

Detailed Description

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A quasi-experimental pretest / posttest design will be used. During a four-week baseline period, researchers will collect data on engagement, quality of life, neuropsychiatric symptoms, and quality of the care-patient relationship. Participants will then use the BRAIN app for four weeks, during which engagement data will be collect. After the intervention period, researchers will collect data again on quality of life, neuropsychiatric symptoms, and quality of the carer-patient relationship.

Conditions

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Dementia Dementia, Vascular Alzheimer Disease Dementia, Mixed

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive the intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

BRAIN Intervention

Group Type EXPERIMENTAL

The BRAIN App

Intervention Type BEHAVIORAL

The BRAIN App will be the first-ever artificial intelligence enabled cognitive stimulation therapy app, specifically designed for PWD. The goal of the app is to foster positive relationships between the care triad.

Interventions

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The BRAIN App

The BRAIN App will be the first-ever artificial intelligence enabled cognitive stimulation therapy app, specifically designed for PWD. The goal of the app is to foster positive relationships between the care triad.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* diagnosed with dementia (any type)
* resident in ALF or NH
* 65+ years old
* read and speak English
* exhibit at least one responsive behavior on the NPI-NH or score below maximum score on the DEMQOL


* 18+ years old
* speak and read English

Exclusion Criteria

* bed-confined
* completely unable to communicate verbally
* have serious visual or hearing impairments
* show signs of rapid decline or over the last six months


-n/a
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopeful Aging

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Skrajner, MA

Role: PRINCIPAL_INVESTIGATOR

Hopeful Aging

Locations

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The Hearthstone Institute

Winchester, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R43AG071105-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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