The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia

NCT05515679 | Completed Results

• 1 other identifier: 1R43AG071105-01A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Dementia, Vascular; Alzheimer Disease; Dementia, Mixed

Keywords

psychosocial; non-pharmacological

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)

  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)

  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

  Baseline (Week 1) and Post-Training (Week 5)

• Percent of Staff Who Thought Residents Enjoyed BRAIN Activities

  Post-Treatment (Week 11)

• Percent of Staff Who Said They Would Recommend the BRAIN App to Colleagues

  Post-Treatment (Week 11)

Study Arms (1)

Treatment

EXPERIMENTAL

BRAIN Intervention

Behavioral: The BRAIN App

Interventions

The BRAIN App 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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• bed-confined
• completely unable to communicate verbally
• have serious visual or hearing impairments
• show signs of rapid decline or over the last six months
• + years old
• speak and read English
• n/a

Sponsors & Collaborators

• Hopeful Aging: lead

Study Sites (1)

The Hearthstone Institute

Winchester, Massachusetts, 01890, United States

Location

MeSH Terms

Conditions

Dementia; Dementia, Vascular; Alzheimer Disease; Mixed Dementias

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Michael Skrajner
• Organization: Hopeful Aging

info@hopefulaging.com

4404777881

Study Officials

• Michael Skrajner, MA

  Hopeful Aging

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive the intervention

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 25, 2022
• Study Start: July 13, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 31, 2022
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)