The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia

Sponsor
The Hearthstone Institute, LLC (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05515679
Collaborator
(none)
68
1
1
6.6
10.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The BRAIN App
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will receive the interventionAll participants will receive the intervention
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia
Actual Study Start Date :
Jul 13, 2022
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

BRAIN Intervention

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Menorah Park Engagement Scale (MPES) [Baseline--that is, week 1 thru week 4]

    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.

  2. Menorah Park Engagement Scale (MPES) [Treatment--that is, week 5 thru week 8]

    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.

  3. Engagement for Persons with Dementia Scale (EPWDS) [Baseline--that is, week 1 thru week 4]

    This scale measures the engagement in 5 domains: affective, visual, verbal, behavioral and social.

  4. Engagement for Persons with Dementia Scale (EPWDS) [Treatment--that is, week 5 thru week 8]

    This scale measures the engagement in 5 domains: affective, visual, verbal, behavioral and social.

Secondary Outcome Measures

  1. Dementia Related Quality of Life (DEMQOL) [Baseline--that is, week 1 thru week 4]

    The DEMQOL measures quality of life, composed of 28 items. It also has a proxy version

  2. Dementia Related Quality of Life (DEMQOL) [Post-Treatment--that is week 5 thru 6]

    The DEMQOL measures quality of life, composed of 28 items. It also has a proxy version

  3. Neuropsychiatric Inventory--Nursing Home (NPI-NH) [Baseline--that is, week 1 thru week 4]

    The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.

  4. Neuropsychiatric Inventory--Nursing Home (NPI-NH) [Post-Treatment--that is week 5 thru 6]

    The NPI-NH measures 12 types of neuropsychiatric symptoms, including their severity and frequency.

  5. Quality of Carer-Patient Relationship (QCPR) [Baseline--that is, week 1 thru week 4]

    This 14-item scale measures warmth and/or absence of conflict or critique on a 5-point scale

  6. Quality of Carer-Patient Relationship (QCPR) [Post-Treatment--that is week 5 thru 6]

    This 14-item scale measures warmth and/or absence of conflict or critique on a 5-point scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hearthstone Institute Winchester Massachusetts United States 01890

Sponsors and Collaborators

  • The Hearthstone Institute, LLC

Investigators

  • Principal Investigator: Michael Skrajner, MA, The Hearthstone Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Hearthstone Institute, LLC
ClinicalTrials.gov Identifier:
NCT05515679
Other Study ID Numbers:
  • 1R43AG071105-01A1
First Posted:
Aug 25, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Hearthstone Institute, LLC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022