Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05516147 |
| Other study ID # |
R43AG075974 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 19, 2024 |
| Est. completion date |
March 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Hopeful Aging |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Aim 1. Develop an Alpha version of the SAFE at Home app, including app infrastructure and
preliminary activity content for live group sessions, as well as staff training and coaching
modules. During Months 1-6, the Development Team (DT) will create the initial product design
and prototype for use in the study. The study team will engage 5 PWD, 5 family members, and 5
activity professionals in focus groups to review the mockups and to understand end user
preferences in terms of user experience and activity content. This will be the only
involvement for these participants. New participants will be recruited for the
quasi-experiment (described below). Aim 2. Examine the app's acceptability/feasibility (by
assessing attendance, session length, and engagement/affect) During Months 5-10, the
Experimental Team (ET) will utilize a quasi-experimental pre-post design (i.e., baseline vs.
treatment / post-treatment) to conduct a two-month long acceptability and feasibility trial
of SaH. During this trial 15 PWD, 15 Family Members, and 5 Life Enrichment professionals will
use the product to determine functionality, acceptability, and feasibility. Baseline and
Onboarding (Month 7). PWD: During the 4-week baseline period, the ET will collect the
following data. PWD Demographics, medications, diagnoses, and type of dementia will be
collected via proxy (family member) interview. The following assessments will be administered
directly: the Short Portable Mental Status Questionnaire (SPMSQ-T), the Dementia Quality of
Life Scale (DEMQOL), the Geriatric Depression Scale-Short Form (GDS-SF), and the UCLA
Loneliness Scale (ULS). Researchers will interview family members (FMs) using the
Neuropsychiatric Inventory-Nursing Home (NPI-NH). Using the Menorah Park Engagement Scale.
researchers will observe PWD engagement and affect via videoconference on four days. This
will allow us to determine "normal/baseline" engagement levels for each PWD and serve as a
comparison for SaH. At the conclusion of the Baseline data collection, the ET will use the
Get to Know You Portal with each PWD to determine their Cognitive and Communication levels as
well as their interests. For the purposes of testing the feasibility of the SaH intervention,
all group assignments will be made solely through the use of SaH tools. Staff Demographics
will be collected. Staff will also take pre-training quizzes prior to taking the training
modules. Family Members (FMs) will provide demographic information and serve as proxies for
the above PWD measures. Intervention Period (Months 8-9). PWD: During the 8-week intervention
period, PWD will participate in SaH sessions through the Social Engagement Portal. Sessions
will occur twice per week and last 30-45 minutes. Staff: Staff will take the training modules
developed in Aim 1 and will also run a simulated group and provide feedback. FMs will be
involved simply by helping set up the hardware and helping their loved one with technical
issues as needed (e.g., reconnecting to the videoconference if the connection is lost). Post
Intervention Period (Month 10). PWD: The DEMQOL, GDS-SF, ULS, and NPI-NH will be
re-administered at Post-Intervention, allowing us to investigate possible long-term effects.
Changes on these longer-term measures are not expected in this Phase 1 study. However, data
will be used to conduct power analyses for Phase 2. Staff: Staff will take post-training
quizzes after completing the training modules. FMs will serve as proxies for some of the
above measures. Milestones. This Aim will be considered successfully met if: (1) At least 85%
of PWD agree to take part in 80% of the sessions. (2) Mean session length is least 25
minutes. (3) PWD exhibit higher levels of positive engagement/affect and lower levels of
negative engagement during SaH sessions, as compared to baseline (based upon the MPES). This
will be assessed by using paired samples t-tests. With the proposed sample, there will be a
power of 99% to detect effects. A detailed power analysis is included in Clinical
Trials-Statistical Design and Power. (4) Staff show an increase in knowledge after taking the
training modules, based upon paired samples t-tests (pre-training quizzes vs. post-training
quizzes). Aim 3. Examine satisfaction with the app by directly eliciting feedback from PWD
and life enrichment staff. Overview: This Aim occurs concurrently with the Intervention
Period for Aim 2 and utilizes the same sample and procedures-it merely tracks separate
outcomes. Intervention Period (Months 8-9). PWD: During the intervention period, PWD will
answer questions related to satisfaction at the end of each session. Staff: Staff will answer
satisfaction questions related to the course and to the app (after the run a simulated
group). FMs will answer satisfaction questions at the end of the study. Challenges. Since
this aim occurs concurrently with Aim 2, no distinct challenges related solely to Aim 3 are
expected. Milestones: This Aim will be considered successfully met if PWD, staff members, and
FMs report high satisfaction with the app, defined as 85% being satisfied or very satisfied.
