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The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia (BRAIN)

Primary Purpose

Dementia, Dementia, Vascular, Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The BRAIN App
Sponsored by
The Hearthstone Institute, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring psychosocial, non-pharmacological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PWD 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

PWD 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

Staff and Family Member Inclusion Criteria

  • 18+ years old
  • speak and read English

Staff and Family Member Exclusion Criteria

-n/a

Sites / Locations

  • The Hearthstone Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

BRAIN Intervention

Outcomes

Primary Outcome Measures

Menorah Park Engagement Scale (MPES)
The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing.
Menorah Park Engagement Scale (MPES)
The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing.
Engagement for Persons with Dementia Scale (EPWDS)
This scale measures the engagement in 5 domains: affective, visual, verbal, behavioral and social.
Engagement for Persons with Dementia Scale (EPWDS)
This scale measures the engagement in 5 domains: affective, visual, verbal, behavioral and social.

Secondary Outcome Measures

Dementia Related Quality of Life (DEMQOL)
The DEMQOL measures quality of life, composed of 28 items. It also has a proxy version
Dementia Related Quality of Life (DEMQOL)
The DEMQOL measures quality of life, composed of 28 items. It also has a proxy version
Neuropsychiatric Inventory--Nursing Home (NPI-NH)
The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.
Neuropsychiatric Inventory--Nursing Home (NPI-NH)
The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.
Quality of Carer-Patient Relationship (QCPR)
This 14-item scale measures warmth and/or absence of conflict or critique on a 5-point scale
Quality of Carer-Patient Relationship (QCPR)
This 14-item scale measures warmth and/or absence of conflict or critique on a 5-point scale

Full Information

First Posted
August 10, 2022
Last Updated
March 28, 2023
Sponsor
The Hearthstone Institute, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05515679
Brief Title
The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia
Acronym
BRAIN
Official Title
The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hearthstone Institute, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Dementia, Vascular, Alzheimer Disease, Dementia, Mixed
Keywords
psychosocial, non-pharmacological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
BRAIN Intervention
Intervention Type
Behavioral
Intervention Name(s)
The BRAIN App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Menorah Park Engagement Scale (MPES)
Description
The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing.
Time Frame
Baseline--that is, week 1 thru week 4
Title
Menorah Park Engagement Scale (MPES)
Description
The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing.
Time Frame
Treatment--that is, week 5 thru week 8
Title
Engagement for Persons with Dementia Scale (EPWDS)
Description
This scale measures the engagement in 5 domains: affective, visual, verbal, behavioral and social.
Time Frame
Baseline--that is, week 1 thru week 4
Title
Engagement for Persons with Dementia Scale (EPWDS)
Description
This scale measures the engagement in 5 domains: affective, visual, verbal, behavioral and social.
Time Frame
Treatment--that is, week 5 thru week 8
Secondary Outcome Measure Information:
Title
Dementia Related Quality of Life (DEMQOL)
Description
The DEMQOL measures quality of life, composed of 28 items. It also has a proxy version
Time Frame
Baseline--that is, week 1 thru week 4
Title
Dementia Related Quality of Life (DEMQOL)
Description
The DEMQOL measures quality of life, composed of 28 items. It also has a proxy version
Time Frame
Post-Treatment--that is week 5 thru 6
Title
Neuropsychiatric Inventory--Nursing Home (NPI-NH)
Description
The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.
Time Frame
Baseline--that is, week 1 thru week 4
Title
Neuropsychiatric Inventory--Nursing Home (NPI-NH)
Description
The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.
Time Frame
Post-Treatment--that is week 5 thru 6
Title
Quality of Carer-Patient Relationship (QCPR)
Description
This 14-item scale measures warmth and/or absence of conflict or critique on a 5-point scale
Time Frame
Baseline--that is, week 1 thru week 4
Title
Quality of Carer-Patient Relationship (QCPR)
Description
This 14-item scale measures warmth and/or absence of conflict or critique on a 5-point scale
Time Frame
Post-Treatment--that is week 5 thru 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PWD 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 PWD 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 Staff and Family Member Inclusion Criteria 18+ years old speak and read English Staff and Family Member Exclusion Criteria -n/a
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Skrajner, MA
Organizational Affiliation
The Hearthstone Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hearthstone Institute
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia

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