DementiaBRAINNCT05515679
The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia
A study testing The BRAIN App in people with Dementia and Dementia, Vascular, run by Hopeful Aging at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Dementia, Vascular, Alzheimer Disease
- What is being tested?
- The BRAIN App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hearthstone Institute
Winchester, Massachusetts, 01890
About this study
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.
Read the 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.
- Conditions
- Dementia, Dementia, Vascular, Alzheimer Disease, Dementia, Mixed
- Being tested
- The BRAIN App
- Keywords
- psychosocial, non-pharmacological
- Medical subject headings
- Dementia, Dementia, Vascular, Alzheimer Disease, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BRAIN AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | BRAIN Intervention Receives: Behavioral: The BRAIN App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-Treatment (Week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start13 Jul 2022
- Primary completion15 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the intervention
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopeful Aging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Skrajner, MA, Principal investigator, Hopeful Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515679
- Sponsor's protocol ID
- 1R43AG071105-01A1
- Acronym
- BRAIN
- Status last verified
- Feb 2024
- First submitted
- 10 Aug 2022
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia
- ClinicalTrials.gov ID
- NCT05515679
- Acronym / sponsor ID
- BRAIN / 1R43AG071105-01A1
- Conditions
- Dementia, Dementia, Vascular, Alzheimer Disease, Dementia, Mixed
- Keywords
- psychosocial, non-pharmacological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hopeful AgingIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the intervention
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: The BRAIN AppBRAIN Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The BRAIN AppThe 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. | Behavioural | Treatment |
Primary outcome
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
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.
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
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.
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
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.
Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
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.
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
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.
Change From Baseline to Treatment for Positive Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
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.
Change From Baseline to Treatment for Negative Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
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.
6 secondary outcomes
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
Time frame: 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)
Time frame: 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
Time frame: Baseline (Week 1) and Post-Training (Week 5)
Percent of Staff Who Thought Residents Enjoyed BRAIN Activities
Time frame: Post-Treatment (Week 11)
Percent of Staff Who Said They Would Recommend the BRAIN App to Colleagues
Time frame: Post-Treatment (Week 11)
Percent of Staff Who Said They Thought the BRAIN App Would Improve Quality of Life of Persons With Dementia.
Time frame: Post-Treatment (Week 11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Skrajner, MA principal investigator
Hopeful Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BRAIN App in people with Dementia and Dementia, Vascular, run by Hopeful Aging at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale (time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.