N/A
N=10
SAFE at Home: A Service to Provide Social Engagement to Community-Dwelling Persons With Dementia
Alzheimer Disease · Dementia · Dementia, Vascular · Dementia, Mixed
Bottom Line
View on ClinicalTrials.gov: NCT05516147 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Constructive Engagement Mean on Menorah Park Engagement Scale — 1.22 score on a scale — p=<.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SAFE at Home (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hopeful Aging
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Constructive Engagement Mean on Menorah Park Engagement Scale |
1.22 | <.01 sig |
| PRIMARY Passive Engagement Mean on Menorah Park Engagement Scale |
1.65 | <.01 sig |
| PRIMARY Other Engagement Mean on Menorah Park Engagement Scale |
0.17 | 0.06 |
| PRIMARY Non Engagement Mean on Menorah Park Engagement Scale |
0.001 | <.01 sig |
| PRIMARY Pleasure Mean on Menorah Park Engagement Scale |
0.72 | — |
| SECONDARY Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL) |
0.85 | 0.81 |
| SECONDARY Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS) |
-3.38 | 0.20 |
| SECONDARY Change From Baseline to Treatment on the University of California, Los Angels (UCLA) Loneliness Scale |
-0.71 | 0.83 |
| SECONDARY Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF) |
-1.00 | 0.320 |
Summary
The proposed Phase 1 study will involve initial development and evaluation of a new service called Social Activities For Engagement at Home or SAFE at Home (SaH). SaH will enable PWD to participate in videoconference-based group activities with their peers-i.e., other PWD. SaH sessions will be facilitated by highly trained "Engagement Professionals," who will be SaH staff members that have a background in recreation therapy, activity coordination, or a similar field. The proposed study has three Specific Aims: Aim 1. Develop an Alpha version of the SaH app, including app infrastructure and preliminary activity content for live group sessions, as well as staff training and coaching modules. Aim 2. Examine the app's acceptability/feasibility (by assessing attendance, session length, and engagement/affect). Aim 3. Examine satisfaction with the app by directly eliciting feedback from PWD and life enrichment staff.
Eligibility Criteria
PWD Inclusion Criteria:
- 65+ years old
- speak and read conversational English
- diagnosed with dementia (any type)
PWD Exclusion Criteria:
-signs of rapid cognitive decline or physical deterioration over the last six months, as evidenced by medical records.
Data sourced from ClinicalTrials.gov (NCT05516147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.