Alzheimer Disease, Dementia, Neurodegenerative Diseases
Conditions
Keywords
technology, dementia, Alzheimer's disease, virtual, behavioral, cognitive, immersive, caregiver, digital health, videogame, memory, non-pharmacological
Brief summary
This Phase 1 study looks at how a new videogame-based program can help residents and care partners prepare for ADLs in a fun way with minimal risk, potentially reducing escalating problems associated with ADL completions.
Detailed description
Central themes in person-centered care are dignity/respect/choice for the care recipient. This Phase l clinical study is a minimal risk study that focuses on how the new technology can support and amplify these principles, while assisting care staff. The investigators will use a novel digital health device developed with user-centered design principles, mirroring a range of evidence-based non-pharmacological interventions for people living with Alzheimer's disease and its related dementias (AD/ADRD). This is a purpose-built virtual world depicting activities of daily living (ADLs). It contains interactive engagement stimuli, including customized digital artifacts that hold meaning to the person. The investigators hypothesize that undertaking ADL-related virtual activities will support completions of actual ADLs, thereby increasing effectiveness and improving care outcomes. Aim 1: Feasibility Successful outcomes are \>55% participation rate and a statistically significant difference between assessments of participation and non-participation, indicating tolerability and acceptability of routine interventions. Aim 2: Effectiveness Successful outcomes are: * a reduction in ADL-related care challenges compared to baseline * reduced time spent on the evening ADLs compared to baseline * a reduction in negative response behaviors associated with the ADL * greater interest in the ADL * a positive shift in care staff attitudes
Interventions
DEVICEA novel digital health device
A videogame-generated virtual world designed for the AD/ADRD care dyad.
Sponsors
National Institute on Aging (NIA)
mandy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A Virtual Game Environment as a Behavioral Intervention for Alzheimer Disease
Eligibility
Sex/Gender
ALL
Age
No minimum to 110 Years
Healthy volunteers
No
Inclusion criteria
The subject will have a diagnosis of AD/ADRD, or symptoms of an undiagnosed AD/ADRD as observed by professional care staff and confirmed by the head of clinical care. The investigators will neither include nor exclude participation based on cognitive test scores. The subject will have had challenge(s) completing one or more ADLs in the previous month, as discussed at staff meetings, referenced in care plans, or observed/experienced by direct care staff. Other specifications: * Understand English or Russian. * Can sit comfortably for at least 15 minutes in a chair/wheelchair at a table or propped up in bed or princess chair with a tray table * Are not known to be in pain * Have good vision, or good corrected vision (i.e., glasses) * Have good hearing, or good corrected hearing (i.e., aids) * May sometimes have anxiety or agitation when undertaking ADLs.
Exclusion criteria
Ineligible subjects are those with significant non-AD/ADRD neurological, psychiatric, or physical impairment or those who are totally dependent upon others for ADLs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe) | 6 weeks | 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. |
| The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The Minimum and Maximum Values Are A Higher Score Means a Better or Worse Outcome. | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Approaches to Dementia Questionnaire (ADQ) | 6 weeks | 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. |
| Sense of Competence in Dementia Care Staff (SCIDS) Scale | 6 weeks | 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. |
| The Copenhagen Burnout Index | 6 weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Persons Living With Dementia Residing in Memory Care Communities 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. | 24 |
| Professional Dementia Caregivers in Memory Care Communities Subjects are the allocated caregivers of the primary participants (i.e., persons living with dementia residing in memory care communities) | 9 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Persons Living With Dementia Residing in Memory Care Communities | Total | Professional Dementia Caregivers in Memory Care Communities |
|---|---|---|---|
| ADCS-ADL | 18.9 score on a scale STANDARD_DEVIATION 8.3 | 18.9 score on a scale STANDARD_DEVIATION 8.3 | — |
| ADQ | — | 60.2 score on a scale STANDARD_DEVIATION 2.28 | 60.2 score on a scale STANDARD_DEVIATION 2.28 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 24 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 9 Participants | 9 Participants |
| Age, Continuous | 81.1 mean/standard deviation STANDARD_DEVIATION 8.9 | 71.6 mean/standard deviation STANDARD_DEVIATION 22.3 | 36.7 mean/standard deviation STANDARD_DEVIATION 14.3 |
| CBI | — | 116.2 score on a scale STANDARD_DEVIATION 18.8 | 116.2 score on a scale STANDARD_DEVIATION 18.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 29 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| NPI-NH | 20.6 score on a scale STANDARD_DEVIATION 10.28 | 20.6 score on a scale STANDARD_DEVIATION 10.28 | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 21 Participants | 0 Participants |
| Region of Enrollment United States | 24 participants | 33 participants | 9 participants |
| SCIDS | — | 45.75 score on a scale STANDARD_DEVIATION 4.09 | 45.75 score on a scale STANDARD_DEVIATION 4.09 |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 10 |
| other Total, other adverse events | 0 / 28 | 0 / 10 |
| serious Total, serious adverse events | 0 / 28 | 0 / 10 |
Outcome results
Primary
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe)
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.
Time frame: 6 weeks
Population: From twenty-four resident participant surveys, eight were excluded from analysis because surveys were a) not filled out or b) incomplete.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons Residing in Long-term Care Homes | Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe) | 19.1 score on a scale | Standard Deviation 9.9 |
p-value: <0.46t-test, 1 sided
Primary
The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) The Minimum and Maximum Values Are A Higher Score Means a Better or Worse Outcome.
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.
Time frame: 6 weeks
Population: From twenty-four resident participant surveys, eight were excluded from analysis because surveys were a) not filled out or b) incomplete.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons Residing in Long-term Care Homes | 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 |
p-value: <0.00314t-test, 1 sided
Secondary
Approaches to Dementia Questionnaire (ADQ)
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons Residing in Long-term Care Homes | Approaches to Dementia Questionnaire (ADQ) | 63.3 score on a scale | Standard Deviation 3.21 |
p-value: <0.066t-test, 1 sided
Secondary
Sense of Competence in Dementia Care Staff (SCIDS) Scale
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons Residing in Long-term Care Homes | Sense of Competence in Dementia Care Staff (SCIDS) Scale | 45.75 score on a scale | Standard Deviation 4.08 |
p-value: <0.085t-test, 1 sided
Secondary
The Copenhagen Burnout Index
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
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons Residing in Long-term Care Homes | The Copenhagen Burnout Index | 51.5 score on a scale | Standard Deviation 9.23 |
p-value: <0.0716t-test, 1 sided