Trial Outcomes & Findings for The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia (NCT NCT05515679)
NCT ID: NCT05515679
Last Updated: 2024-03-13
Results Overview
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.
COMPLETED
NA
45 participants
Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
2024-03-13
Participant Flow
Participant milestones
| Measure |
Persons With Dementia
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
Staff Members
Staff members participated by providing feedback on the app and training. In addition, staff took pre- and post-quizzes for the training.
|
Family Members
Family members exclusively participated by providing information about their loved one's (i.e., person with dementia's) background, interests and preferences. Please note: although we originally expected one family some persons with dementia did not have a family member available who could be contacted regarding their background, interests, and preferences. As such, the total number of family members is not equal to the persons with dementia. When a family member want not available, information about the person with dementia was obtained by the person with dementia himself or herself.
|
|---|---|---|---|
|
Baseline
STARTED
|
22
|
13
|
10
|
|
Baseline
COMPLETED
|
22
|
13
|
10
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment
STARTED
|
22
|
13
|
0
|
|
Treatment
COMPLETED
|
22
|
13
|
0
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
0
|
|
Post-Treatment
STARTED
|
22
|
13
|
0
|
|
Post-Treatment
COMPLETED
|
22
|
13
|
0
|
|
Post-Treatment
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The BRAIN App: Building Relationships Using Artificial Intelligence and Nostalgia
Baseline characteristics by cohort
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
Staff Members
n=13 Participants
Staff members participated by providing feedback on the app and training. In addition, staff took pre- and post-quizzes for the training.
|
Family Members
n=10 Participants
Family members exclusively participated by providing information about their loved one's (i.e., person with dementia's) background, interests and preferences. As such, there is no outcome data for family members. Please note: although we originally expected one family some persons with dementia did not have a family member available who could be contacted regarding their background, interests, and preferences. As such, the total number of family members is not equal to the persons with dementia. When a family member want not available, information about the person with dementia was obtained by the person with dementia himself or herself.
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Total
n=45 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Continuous
|
83.73 years
STANDARD_DEVIATION 6.53 • n=5 Participants
|
45.92 years
STANDARD_DEVIATION 11.67 • n=7 Participants
|
65.00 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
68.6 years
STANDARD_DEVIATION 18.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
13 participants
n=7 Participants
|
10 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale
|
.72 score on scale
Standard Deviation .48
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
|
-0.33 score on scale
Standard Deviation .60
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
|
-.25 score on scale
Standard Deviation .40
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale
|
-0.15 score on scale
Standard Deviation .34
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
|
.66 score on scale
Standard Deviation .28
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment for Positive Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)
|
4.11 score on scale
Standard Deviation 3.35
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment for Negative Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)
|
-1.07 score on scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline (Weeks 1-4) and Post-Treatment (Week 11)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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
|
6.02 score on scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline (Weeks 1-4) and Post-Treatment (Week 11)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.
Outcome measures
| Measure |
Persons With Dementia
n=22 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
|
1.23 score on scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Baseline (Week 1) and Post-Training (Week 5)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
Outcome measures
| Measure |
Persons With Dementia
n=13 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Change From Pre-Test to Post-Test for the Knowledge Assessment for BRAIN Training for Staff
|
27.43 percent score on quiz out of 100
Standard Deviation .11
|
SECONDARY outcome
Timeframe: Post-Treatment (Week 11)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.
Outcome measures
| Measure |
Persons With Dementia
n=12 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Percent of Staff Who Thought Residents Enjoyed BRAIN Activities
|
100 percentage who said yes
|
SECONDARY outcome
Timeframe: Post-Treatment (Week 11)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.
Outcome measures
| Measure |
Persons With Dementia
n=13 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Percent of Staff Who Said They Would Recommend the BRAIN App to Colleagues
|
100 percentage who said yes
|
SECONDARY outcome
Timeframe: Post-Treatment (Week 11)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.
Outcome measures
| Measure |
Persons With Dementia
n=13 Participants
Persons with dementia (PWD) were the "primary" or "target" participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks.
|
|---|---|
|
Percent of Staff Who Said They Thought the BRAIN App Would Improve Quality of Life of Persons With Dementia.
|
100 percentage who said yes
|
Adverse Events
Persons With Dementia
Staff Members
Family Members
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place