Clinical trial NCT05515679: The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia
Official title: The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Dementia, Vascular
Alzheimer Disease
Dementia, Mixed
Keywords: psychosocial
non-pharmacological
Lead sponsor: Hopeful Aging
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the intervention
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Positive Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
measure: Change From Baseline to Treatment for Negative Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)
timeFrame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Secondary outcomes:
measure: Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
measure: Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
timeFrame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
measure: Change From Pre-Test to Post-Test for the Knowledge Assessment for BRAIN Training for Staff
timeFrame: Baseline (Week 1) and Post-Training (Week 5)
measure: Percent of Staff Who Thought Residents Enjoyed BRAIN Activities
timeFrame: Post-Treatment (Week 11)
measure: Percent of Staff Who Said They Would Recommend the BRAIN App to Colleagues
timeFrame: Post-Treatment (Week 11)
measure: Percent of Staff Who Said They Thought the BRAIN App Would Improve Quality of Life of Persons With Dementia.
timeFrame: Post-Treatment (Week 11)
Other outcomes:
Locations:
city: Winchester
country: United States
facility: The Hearthstone Institute
state: Massachusetts
Study officials:
affiliation: Hopeful Aging
name: Michael Skrajner, MA
role: PRINCIPAL_INVESTIGATOR
References: