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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | BRAIN Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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) |
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PWD Inclusion Criteria:
PWD Exclusion Criteria:
Staff and Family Member Inclusion Criteria
Staff and Family Member Exclusion Criteria
-n/a
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| Name | Affiliation | Role |
|---|---|---|
| Michael Skrajner, MA | Hopeful Aging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hearthstone Institute | Winchester | Massachusetts | 01890 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Staff Members | Staff members participated by providing feedback on the app and training. In addition, staff took pre- and post-quizzes for the training. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Treatment |
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| Post-Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Staff Members |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
|
5 months
Long-term care communities were asked to let the Principal Investigator (PI) know (via email, phone, or in person) about adverse events if/when they occur. In addition, each long-term care community was contacted via email at the end of each month by the PI. In that email, the PI asked the long-term care community whether any adverse events occurred that had not yet been reported. There was no adverse event reporting for staff and family members, as they were not the target of the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Persons With Dementia | Participants in the Treatment group were invited to participate in one-on-one activity sessions using the Phase 1 version of the BRAIN app twice per week for five weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Skrajner | Hopeful Aging | 4404777881 | info@hopefulaging.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2022 | Feb 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2022 | Jan 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D015140 | Dementia, Vascular |
| D000544 | Alzheimer Disease |
| D000093902 | Mixed Dementias |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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All participants will receive the intervention
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| 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) |
| 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) |
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Staff members participated by providing feedback on the app and training. In addition, staff took pre- and post-quizzes for the training. |
| BG002 | Family Members | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Post-Treatment (Week 11) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Weeks 1-4) and Post-Treatment (Week 11) |
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| Secondary | 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 | Posted | Mean | Standard Deviation | percent score on quiz out of 100 | Baseline (Week 1) and Post-Training (Week 5) |
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| Secondary | 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. | Posted | Number | percentage who said yes | Post-Treatment (Week 11) |
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| Secondary | 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. | Posted | Number | percentage who said yes | Post-Treatment (Week 11) |
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| Secondary | 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. | Posted | Number | percentage who said yes | Post-Treatment (Week 11) |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Staff Members | Staff members participated by providing feedback on the app and training. In addition, staff took pre- and post-quizzes for the training. NOTE: Staff members were not at risk during the study, because they were not the target of the intervention itself. Instead, they merely provided feedback about the app and took pre and post tests. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Family Members | Family members exclusively participated by providing information about their loved one's (i.e., person with dementia's) background, interests and preferences. NOTE: Family members were not at risk during the study, because they were not the target of the intervention itself. Instead, they merely provided background information about their loved one. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |