Trial Outcomes & Findings for Assessing a Novel Virtual Environment That Assists With Activities of Daily Living (NCT NCT05418296)
NCT ID: NCT05418296
Last Updated: 2025-02-10
Results Overview
The ADCS-ADL assesses the competence of patients with Alzheimer's Disease (AD) in basic and instrumental activities of daily living (ADLs). It can be completed by a caregiver in questionnaire format, or administered by a clinician/researcher as a structured interview with a caregiver. There are 19 questions. The minimum and maximum values are 0 - 54. A higher score means a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Persons Living With Dementia Residing in Memory Care Communities
Subjects' ADLs are studied with intervention compared to baseline (without intervention).
A novel digital health device: A videogame-generated virtual world designed for the AD/ADRD care dyad.
|
Professional Dementia Caregivers in Memory Care Communities
Subjects are caregivers of the primary participants, ie persons living with dementia
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
10
|
|
Overall Study
COMPLETED
|
24
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Persons Living With Dementia Residing in Memory Care Communities
Subjects' ADLs are studied with intervention compared to baseline (without intervention).
A novel digital health device: A videogame-generated virtual world designed for the AD/ADRD care dyad.
|
Professional Dementia Caregivers in Memory Care Communities
Subjects are caregivers of the primary participants, ie persons living with dementia
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Does not apply to this group
Baseline characteristics by cohort
| Measure |
Persons Living With Dementia Residing in Memory Care Communities
n=24 Participants
Subjects' ADLs are studied with intervention compared to baseline (ie., without intervention).
A novel digital health device: A videogame-generated virtual world designed for the AD/ADRD care dyad.
|
Professional Dementia Caregivers in Memory Care Communities
n=9 Participants
Subjects are the allocated caregivers of the primary participants (i.e., persons living with dementia residing in memory care communities)
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=24 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
24 Participants
n=33 Participants
|
|
Age, Continuous
|
81.1 mean/standard deviation
STANDARD_DEVIATION 8.9 • n=24 Participants
|
36.7 mean/standard deviation
STANDARD_DEVIATION 14.3 • n=9 Participants
|
71.6 mean/standard deviation
STANDARD_DEVIATION 22.3 • n=33 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=24 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
14 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
4 Participants
n=9 Participants
|
4 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=24 Participants
|
5 Participants
n=9 Participants
|
29 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
21 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
4 Participants
n=9 Participants
|
4 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=33 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
9 participants
n=9 Participants
|
33 participants
n=33 Participants
|
|
ADCS-ADL
|
18.9 score on a scale
STANDARD_DEVIATION 8.3 • n=16 Participants • Does not apply to this group
|
—
|
18.9 score on a scale
STANDARD_DEVIATION 8.3 • n=16 Participants • Does not apply to this group
|
|
NPI-NH
|
20.6 score on a scale
STANDARD_DEVIATION 10.28 • n=24 Participants • Does not apply to this group
|
—
|
20.6 score on a scale
STANDARD_DEVIATION 10.28 • n=24 Participants • Does not apply to this group
|
|
ADQ
|
—
|
60.2 score on a scale
STANDARD_DEVIATION 2.28 • n=9 Participants • Does not apply to this group
|
60.2 score on a scale
STANDARD_DEVIATION 2.28 • n=9 Participants • Does not apply to this group
|
|
SCIDS
|
—
|
45.75 score on a scale
STANDARD_DEVIATION 4.09 • n=9 Participants • Does not apply to this group
|
45.75 score on a scale
STANDARD_DEVIATION 4.09 • n=9 Participants • Does not apply to this group
|
|
CBI
|
—
|
116.2 score on a scale
STANDARD_DEVIATION 18.8 • n=9 Participants • Does not apply to this group
|
116.2 score on a scale
STANDARD_DEVIATION 18.8 • n=9 Participants • Does not apply to this group
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: From twenty-four resident participant surveys, eight were excluded from analysis because surveys were a) not filled out or b) incomplete.
The ADCS-ADL assesses the competence of patients with Alzheimer's Disease (AD) in basic and instrumental activities of daily living (ADLs). It can be completed by a caregiver in questionnaire format, or administered by a clinician/researcher as a structured interview with a caregiver. There are 19 questions. The minimum and maximum values are 0 - 54. A higher score means a better outcome.
Outcome measures
| Measure |
Persons Residing in Long-term Care Homes
n=16 Participants
Participants' ADLs were studied with intervention compared to baseline (without intervention) to identify care dyad acceptance and measure its impact on ADL management.
Primary participants (memory care residents with AD/ADRD or symptoms of undiagnosed AD/ADRD), across two sites, were introduced to a novel digital health device, "DevaWorld", a videogame-generated virtual home that simulates common ADL activities. The program, which is deployed on touchscreen tablets, contains objects and locations commonly found in the home. Two rooms were selected for the study, a bedroom and a bathroom. A male (Robin) or female (Julie), avatar who reside in the virtual home provided a context for activities, such as "Help Julie clean her teeth" or, "What will Robin wear today?". Graphical 3D objects relevant to the activities under study animate responded to screen taps, and the avatar provided verbal prompts to guide and encourage the participant.
Participants were supported by an allocated staff- participant recruited to the study. These were regular frontline carers known to the participants who had self-selected for the study from a pool nominated by care team managers. They were formally recruited and underwent training to manage the intervention (both the program and the tablet device on which the program was deployed)
DevaWorld sessions were run at various times of the day to fit in with staff's daily work flow and availability.
|
|---|---|
|
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe)
|
19.1 score on a scale
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: From twenty-four resident participant surveys, eight were excluded from analysis because surveys were a) not filled out or b) incomplete.
The NPI-NH The NPI-NH has been used to characterize the psychopathology of patients in nursing homes as well as to measure the impact of anti dementia and psychotropic drugs and behavioral changes in dementia patients dwelling in nursing homes. There are questions. The minimum and maximum values are 12 - 120 A lower score means a better outcome.
Outcome measures
| Measure |
Persons Residing in Long-term Care Homes
n=16 Participants
Participants' ADLs were studied with intervention compared to baseline (without intervention) to identify care dyad acceptance and measure its impact on ADL management.
Primary participants (memory care residents with AD/ADRD or symptoms of undiagnosed AD/ADRD), across two sites, were introduced to a novel digital health device, "DevaWorld", a videogame-generated virtual home that simulates common ADL activities. The program, which is deployed on touchscreen tablets, contains objects and locations commonly found in the home. Two rooms were selected for the study, a bedroom and a bathroom. A male (Robin) or female (Julie), avatar who reside in the virtual home provided a context for activities, such as "Help Julie clean her teeth" or, "What will Robin wear today?". Graphical 3D objects relevant to the activities under study animate responded to screen taps, and the avatar provided verbal prompts to guide and encourage the participant.
Participants were supported by an allocated staff- participant recruited to the study. These were regular frontline carers known to the participants who had self-selected for the study from a pool nominated by care team managers. They were formally recruited and underwent training to manage the intervention (both the program and the tablet device on which the program was deployed)
DevaWorld sessions were run at various times of the day to fit in with staff's daily work flow and availability.
|
|---|---|
|
The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The Minimum and Maximum Values Are A Higher Score Means a Better or Worse Outcome.
|
12.2 score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All data collected were analysed for five staff participants. Surveys of four were excluded from analysis because surveys were a) not filled out or b) incomplete.
The ADQ is a validated questionnaire that aims to assess participants' attitudes towards dementia, and has been shown to be reliable, easy to administer and to score. The ADQ is a 19-item survey that assesses attitudes towards people living with dementia using a five-point Likert scale ranging from 'strongly agree' to 'strongly disagree'. The total ADQ score ranges from 19 to 95, with higher scores reflecting more positive attitudes towards people living with dementia.
Outcome measures
| Measure |
Persons Residing in Long-term Care Homes
n=5 Participants
Participants' ADLs were studied with intervention compared to baseline (without intervention) to identify care dyad acceptance and measure its impact on ADL management.
Primary participants (memory care residents with AD/ADRD or symptoms of undiagnosed AD/ADRD), across two sites, were introduced to a novel digital health device, "DevaWorld", a videogame-generated virtual home that simulates common ADL activities. The program, which is deployed on touchscreen tablets, contains objects and locations commonly found in the home. Two rooms were selected for the study, a bedroom and a bathroom. A male (Robin) or female (Julie), avatar who reside in the virtual home provided a context for activities, such as "Help Julie clean her teeth" or, "What will Robin wear today?". Graphical 3D objects relevant to the activities under study animate responded to screen taps, and the avatar provided verbal prompts to guide and encourage the participant.
Participants were supported by an allocated staff- participant recruited to the study. These were regular frontline carers known to the participants who had self-selected for the study from a pool nominated by care team managers. They were formally recruited and underwent training to manage the intervention (both the program and the tablet device on which the program was deployed)
DevaWorld sessions were run at various times of the day to fit in with staff's daily work flow and availability.
|
|---|---|
|
Approaches to Dementia Questionnaire (ADQ)
|
63.3 score on a scale
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All data collected were analysed for five staff participants. Surveys of four were excluded from analysis because surveys were a) not filled out or b) incomplete.
The SCIDS scale provides a useful and user-friendly means of measuring sense of competence in care staff. There are questions. The minimum and maximum values are 17 - 68 A higher score means a better outcome.
Outcome measures
| Measure |
Persons Residing in Long-term Care Homes
n=5 Participants
Participants' ADLs were studied with intervention compared to baseline (without intervention) to identify care dyad acceptance and measure its impact on ADL management.
Primary participants (memory care residents with AD/ADRD or symptoms of undiagnosed AD/ADRD), across two sites, were introduced to a novel digital health device, "DevaWorld", a videogame-generated virtual home that simulates common ADL activities. The program, which is deployed on touchscreen tablets, contains objects and locations commonly found in the home. Two rooms were selected for the study, a bedroom and a bathroom. A male (Robin) or female (Julie), avatar who reside in the virtual home provided a context for activities, such as "Help Julie clean her teeth" or, "What will Robin wear today?". Graphical 3D objects relevant to the activities under study animate responded to screen taps, and the avatar provided verbal prompts to guide and encourage the participant.
Participants were supported by an allocated staff- participant recruited to the study. These were regular frontline carers known to the participants who had self-selected for the study from a pool nominated by care team managers. They were formally recruited and underwent training to manage the intervention (both the program and the tablet device on which the program was deployed)
DevaWorld sessions were run at various times of the day to fit in with staff's daily work flow and availability.
|
|---|---|
|
Sense of Competence in Dementia Care Staff (SCIDS) Scale
|
45.75 score on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All data collected were analysed for five staff participants. Surveys of four were excluded from analysis because surveys were a) not filled out or b) incomplete.
The Copenhagen Burnout Inventory (CBI) is a 19-item survey that measures burnout in three areas: personal, work-related, and client-related. Scale ranges from 0 to 300, with high scores indicating high levels of burnout. This inventory is self-administered
Outcome measures
| Measure |
Persons Residing in Long-term Care Homes
n=5 Participants
Participants' ADLs were studied with intervention compared to baseline (without intervention) to identify care dyad acceptance and measure its impact on ADL management.
Primary participants (memory care residents with AD/ADRD or symptoms of undiagnosed AD/ADRD), across two sites, were introduced to a novel digital health device, "DevaWorld", a videogame-generated virtual home that simulates common ADL activities. The program, which is deployed on touchscreen tablets, contains objects and locations commonly found in the home. Two rooms were selected for the study, a bedroom and a bathroom. A male (Robin) or female (Julie), avatar who reside in the virtual home provided a context for activities, such as "Help Julie clean her teeth" or, "What will Robin wear today?". Graphical 3D objects relevant to the activities under study animate responded to screen taps, and the avatar provided verbal prompts to guide and encourage the participant.
Participants were supported by an allocated staff- participant recruited to the study. These were regular frontline carers known to the participants who had self-selected for the study from a pool nominated by care team managers. They were formally recruited and underwent training to manage the intervention (both the program and the tablet device on which the program was deployed)
DevaWorld sessions were run at various times of the day to fit in with staff's daily work flow and availability.
|
|---|---|
|
The Copenhagen Burnout Index
|
51.5 score on a scale
Standard Deviation 9.23
|
Adverse Events
Persons Living With Dementia Residing in Memory Care Communities
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Professional Dementia Caregivers in Memory Care Communities
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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