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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Dementia, Vascular; Dementia, Mixed
• Intervention / Treatment: Behavioral: The BRAIN App

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • The Hearthstone Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale	Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.	Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale	Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.	Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale	Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.	Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale	Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.	Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale	Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of "standard" activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.	Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Change From Baseline to Treatment for Positive Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)	The Positive Items Sub-score on the EPWDS is the total score for the five following items: (1) Displays positive affect, (2) maintains eye contact, (3) Initiates, participates, or maintains verbal conversation, sounds or gestures (e.g., nodding) in response to the activity, or the materials used, or the person/s involved, (4) Responds to an activity by approaching, reaching out, touching, holding or handling the activity, the material used, or the person/s involved, and (5) Uses the activity or the material/s to encourage others to interact, or as a communication channel to interact and talk with others (e.g., staff and other residents). During baseline, multiple observations of "standard" activities were observed and a mean was calculated for the positive item sub-score. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value is 0 and the maximum score is 20. Higher scores represent a better outcome.	Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Change From Baseline to Treatment for Negative Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)	The Negative Items Sub-score on the EPWDS is the total score for the five following items: (1) Displays negative affect, (2) Appears inattentive, has an unfocused stare or turns head/eyes away from the activity, materials used, or the person/s involved, (3) Refuses to participate in the activity or in a conversation related to the activity by verbalizing e.g. "no", "stop", etc. OR verbalizes negative comment, complaint, and sound in response to or related to the activity, or the materials used, or the person/s involved, and (4) In response to the activity, is distracting or disrupting others (e.g., Staff/facilitator and other residents). During baseline, multiple observations of "standard" activities were observed and a mean was calculated for the negative item sub-score. Then, again, during treatment, multiple observations were taken and mean was calculate. Total score ranges from 0 to 16. Lower scores represent a better outcome.	Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)	The Dementia Related Quality of Life Scale is a 28 item scale that examines quality of life in persons with dementia. The score ranges for 28 to 112. Higher scores represent a better outcome.	Baseline (Weeks 1-4) and Post-Treatment (Week 11)
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)	The NPI-NH examines 10 types of neuropsychiatric symptoms in persons with dementia, with the FxS score looking creating a composite score that takes into account frequency and severity of the symtoms. The score ranges from 0 to 120. Lower scores represent a better outcome.	Baseline (Weeks 1-4) and Post-Treatment (Week 11)
Change From Pre-Test to Post-Test for the Knowledge Assessment for BRAIN Training for Staff	Staff took a quiz at pre-test and again at post-test. Scores range from 0 to 100, with higher scores representing a better outcome	Baseline (Week 1) and Post-Training (Week 5)
Percent of Staff Who Thought Residents Enjoyed BRAIN Activities	Staff were asked if they thought residents enjoyed using the BRAIN Activities. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome.	Post-Treatment (Week 11)
Percent of Staff Who Said They Would Recommend the BRAIN App to Colleagues	Staff were asked if they would recommend BRAIN Activities to colleagues. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome.	Post-Treatment (Week 11)
Percent of Staff Who Said They Thought the BRAIN App Would Improve Quality of Life of Persons With Dementia.	Staff were asked if they thought the BRAIN app would improve quality of life of persons with dementia.. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome.	Post-Treatment (Week 11)

Collaborators and Investigators

• Sponsor: Hopeful Aging
• Investigators: Principal Investigator: Michael Skrajner, MA, Hopeful Aging

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: psychosocial; non-pharmacological
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Alzheimer Disease; Dementia, Vascular
• Other Study ID Numbers: 1R43AG071105-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No