Trial Outcomes & Findings for SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons With Dementia (NCT NCT05516147)
NCT ID: NCT05516147
Last Updated: 2025-03-21
Results Overview
Constructive Engagement on the Menorah Park Engagement Scale (MPES) is defined as doing or commenting on something related to the target activity. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.
COMPLETED
NA
12 participants
Treatment (Weeks 5-10)
2025-03-21
Participant Flow
Participant milestones
| Measure |
Treatment
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Treatment
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Overall Study
Scheduling Conflicts Made it Impossible for them to participate
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2
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Baseline Characteristics
SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons With Dementia
Baseline characteristics by cohort
| Measure |
Treatment
n=10 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Age, Continuous
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82.40 years
STANDARD_DEVIATION 5.19 • n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Treatment (Weeks 5-10)Constructive Engagement on the Menorah Park Engagement Scale (MPES) is defined as doing or commenting on something related to the target activity. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.
Outcome measures
| Measure |
Treatment
n=10 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
|
|---|---|
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Constructive Engagement Mean on Menorah Park Engagement Scale
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1.22 score on a scale
Standard Deviation 0.32
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PRIMARY outcome
Timeframe: Treatment (Weeks 5-10)Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.
Outcome measures
| Measure |
Treatment
n=10 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Passive Engagement Mean on Menorah Park Engagement Scale
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1.65 score on a scale
Standard Deviation 0.25
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PRIMARY outcome
Timeframe: 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. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.
Outcome measures
| Measure |
Treatment
n=10 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Other Engagement Mean on Menorah Park Engagement Scale
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0.17 score on a scale
Standard Deviation 0.36
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PRIMARY outcome
Timeframe: Treatment (Weeks 5-10)Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Non Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.40 for standard programming.
Outcome measures
| Measure |
Treatment
n=10 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
|
|---|---|
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Non Engagement Mean on Menorah Park Engagement Scale
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0.001 score on a scale
Standard Deviation 0.003
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PRIMARY outcome
Timeframe: Treatment (Weeks 5-10)Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling.For each participant, multiple BRAIN activities were observed during weeks 5-10. Based upon all of these observations that occured during this time period, a single mean score was calculated for each participant on this MPES item. The minimum value for Non Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.28 for standard programming.
Outcome measures
| Measure |
Treatment
n=10 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Pleasure Mean on Menorah Park Engagement Scale
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0.72 score on a scale
Standard Deviation 0.27
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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 |
Treatment
n=8 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
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0.85 score on a scale
Standard Deviation 9.4
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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 |
Treatment
n=8 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
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-3.38 score on a scale
Standard Deviation 6.68
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SECONDARY outcome
Timeframe: Baseline (Weeks 1-4) and Post-Treatment (Week 11)The UCLA Loneliness Scale is a widely used psychological tool designed to measure an individual's subjective feelings of loneliness and social isolation. The 20-item version consists of statements related to social connections, with responses typically rated on a four-point Likert scale (e.g., "Never," "Rarely," "Sometimes," "Often"). Scoring involves summing item responses, with higher scores indicating greater levels of loneliness. The range of total possible score is 20 (least amount of loneliness) to 80 (most amount of loneliness).
Outcome measures
| Measure |
Treatment
n=8 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Change From Baseline to Treatment on the University of California, Los Angels (UCLA) Loneliness Scale
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-0.71 score on a scale
Standard Deviation 8.94
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SECONDARY outcome
Timeframe: Baseline (Weeks 1-4) and Post-Treatment (Week 11)The 15-item Geriatric Depression Scale (GDS-SF) is a screening tool used to assess depressive symptoms in older adults. Each item is answered with a "Yes" or "No"\*\* response, with a total score ranging from 0 to 15, where higher scores indicate greater depressive symptoms. A score of 5 or more\*\* suggests possible depression, warranting further clinical evaluation.
Outcome measures
| Measure |
Treatment
n=8 Participants
SAFE at Home Intervention
SAFE at Home: SAFE at Home will enable community-dwelling PWD to participate in videoconference-based group activities with their peers, that is, other PWD. SaH sessions will be facilitated by highly trained Engagement Professionals.
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|---|---|
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Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)
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-1.00 score on a scale
Standard Deviation 2.67
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Adverse Events
Treatment
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