Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05516134 |
| Other study ID # |
AG077993-01 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 28, 2024 |
| Est. completion date |
June 15, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Hopeful Aging |
| Contact |
Michael Skrajner, MA |
| Phone |
4404777881 |
| Email |
skrajner[@]thehearth.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This Phase I study will involve initial development and evaluation of an innovative
cross-platform software app called All About Me (AAM), which will consist of Serious Digital
Health Games (SDHGs) for PWD. The AAM app will assist staff in providing person-centered care
and enable residents to improve relationships with one another and with staff, thereby
promoting a sense of community. This Phase I study has three Specific Aims: (1) Develop an
Alpha version of the AAM App, (2) Examine acceptability of and satisfaction with the AAM App,
and (3) Examine the impact of the Resident Game Bundle / Survey Says Game on
engagement/affect.
Description:
Study Design: The study will utilize a quasi-experimental pre-post design.
Sample:
PWD: Twenty-four PWD will take part in the study, including 12 ALF residents and 12 living in
a NH.
Family Members: Twenty-four family members will also take part in the study-i.e., one for
each PWD. In some cases, the "family member" may be a friend or legally authorized
representative.
Staff Members: Twelve LTC staff members will take part in the quasi-experiment-five at the
ALF and five at the NH.
Inclusion/Exclusion Criteria:
PWD must reside in an ALF or NH, be 60+ years old, speak and read English, be diagnosed with
dementia (of any type), and score at least eight on the MMSE.
Family Members, LTC Staff Members, and Focus Group Staff Members must be 18+ years old and
speak and read English.
Baseline Period/Measures:
PWD: During Month 8, the following data will be collected via chart review: demographics,
medications, diagnoses (including type of dementia), and primary language. In addition, the
MMSE48 and the Dementia Quality of Life Scale (DEMQOL)50 will be administered via direct
interview. The Neuropsychiatric Inventory-Nursing Home (NPI-NH),51,52 done via staff
interview, will be used to collect data on challenging behaviors. PWD will also be observed
taking part in standard activities using the Menorah Park Engagement Scale (MPES).53 The MPES
is an observational scale that measures four types of engagement: Constructive Engagement
(motor/verbal behavior exhibited clearly in response to the target activity); Passive
Engagement (listening/watching a target activity); Distracted Engagement (motor/verbal
behavior exhibited in response to something other than the target activity); and
Non-Engagement/Apathy (outward signs/indicators of apathy, such as sleeping, closing one's
eyes, and staring into space). The MPES also measures Pleasure, defined as clearly observable
smiling/laughing. MPES data for standard activities will allow us to conduct a robust
comparison to the RGB/Survey Says Game.
Family Members: researchers will interview family members to obtain demographics.
LTC Staff Members: Researchers will only interview staff members to obtain demographics
during Phase I. Since this study is about development and feasibility testing, we do not want
to unnecessarily burden staff with measures in Phase I. In the future Phase II, we will use
the Caregiving Difficulty Scale-Intellectual Disability (CDS-ID)54 and the Maslach Burnout
Inventory (MBI).
Intervention Period/Measures: During Month 9, family members will play the FFAM Game with
their loved one on an Android tablet. A relatively lengthy four-week time period was chosen
to ensure that even very busy family members will find time to play the game. We expect the
game to take 60 minutes to complete, but we will encourage family members to split up the
game into two 30-minute sessions. The app will automatically capture data about how many
questions/items were completed and the length of time to complete the game. In addition,
after playing the FFAM Game, family members and PWD will be asked questions related to ease
of use and satisfaction. During Month 10, PWD will play the RGB/Survey Says Game twice per
week for four weeks. The game will be played on an Android tablet, which will be connected to
a large screen TV. The activity will be facilitated by a researcher; however, each staff
member will observe an RGB/Survey Says Game session at least once, so that they can provide
feedback about the game. An RA (not the researcher facilitating game) will observe PWD with
the MPES while they are taking part in the Survey Says Game. After each Survey Says Game
session, PWD and Staff Members will be asked questions related to ease of use and
satisfaction (e.g., did you find the game easy to use? Did you enjoy the game? Would you
recommend it to others?) During this same time period, LTC staff members will use the MRM
daily when working with PWD. Each staff member will be given an Android smartphone and they
will be encouraged to briefly review information about PWD before interacting with and/or
providing care to them. At the end of this time period, staff will be asked questions related
to ease of use and satisfaction for the MRM (e.g., Did you find it easy to use? Would you
recommend it to others? Did it help you provide better care?)
Treatment Fidelity/Process Measures: In the backend of the app, a variety of treatment
fidelity/process measures will automatically be collected by the app, including dates/times
each participant used the app, length of time for each session; number of buttons pressed in
each activity, and dates/times of any crashes.
Post-Treatment/Distal Measures:
PWD: The DEMQOL and NPI-NH will be re-administered. Family Members: No post-treatment
measures will be taken. LTC Staff Members: No post-treatment measures will be taken.
Please note that, since the purpose of Phase I is to demonstrate proof of concept and
feasibility, and since the intervention period will be relatively brief, changes are not
expected from baseline to post-treatment on longer-term measures (i.e., the DEMQOL and
NPI-NH). These measures are being used in Phase I exclusively to obtain means and standard
deviations to conduct a power analysis to ensure that a sufficiently sized sample is used in
Phase II.
Analyses: The AAM App will be considered successful if the following results are found: (1)
at least 85% of participants complete 85% of the FFAM Game; (2) mean completion time for the
FFAM Game is 45-75 minutes; (3) at least 85% of family members and PWD are satisfied with the
FFAM Game and find it easy to use; (4) for PWD, levels of positive engagement/affect are
higher, and levels of negative engagement are lower, during the Survey Says Game, as compared
to standard programming (based upon a paired sample t-test); with the proposed sample size,
and using means and standard deviations from the previous studies by the PI, we will have a
power of 93% to detect effects (alpha = .05; one-tailed test). (5) at least 85% of PWD and
LTC staff members are satisfied with the Survey Says Game and find it easy to use; and (6) at
least 85% of LTC staff members are satisfied with the My Resident Module and find it easy to
use.
