Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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. |
Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
|
| 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. |
Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
|
| 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. |
Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
|
| 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. |
Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
|
| 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. |
Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
|
| 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. |
Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
|
| 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. |
Baseline (Weeks 1-4) and Treatment (Weeks 5-10) |
|
| 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. |
Baseline (Weeks 1-4) and Post-Treatment (Week 11) |
|
| 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. |
Baseline (Weeks 1-4) and Post-Treatment (Week 11) |
|
| 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 |
Baseline (Week 1) and Post-Training (Week 5) |
|
| 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. |
Post-Treatment (Week 11) |
|
| 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. |
Post-Treatment (Week 11) |
|
| 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. |
Post-Treatment (Week 11) |
|
