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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43AG071102-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persons residing in long-term care homes | Experimental | Subjects' ADLs are studied with intervention compared to baseline (without intervention). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A novel digital health device | Device | A videogame-generated virtual world designed for the AD/ADRD care dyad. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Mandy Salomon, PhD | Mentia DTx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruceville Point Senior Living Community | Elk Grove | California | 95757 | United States | ||
| Elder Ashram |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34140328 | Background | Quail Z, Bolton L, Massey K. Digital delivery of non-pharmacological intervention programmes for people living with dementia during the COVID-19 pandemic. BMJ Case Rep. 2021 Jun 17;14(6):e242550. doi: 10.1136/bcr-2021-242550. | |
| 24635843 | Background | Kahle-Wrobleski K, Coley N, Lepage B, Cantet C, Vellas B, Andrieu S; Plasa DSA Group. Understanding the complexities of functional ability in Alzheimer's disease: more than just basic and instrumental factors. Curr Alzheimer Res. 2014 May;11(4):357-66. doi: 10.2174/1567205011666140317101419. |
| Label | URL |
|---|---|
| Database of best dementia care resources | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Professional Dementia Caregivers in Memory Care Communities | Subjects are caregivers of the primary participants, ie persons living with dementia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Professional Dementia Caregivers in Memory Care Communities |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | From twenty-four resident participant surveys, eight were excluded from analysis because surveys were a) not filled out or b) incomplete. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
One year
No adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Length of study reduced from 8 to 6 weeks due to staff participants' lack of adherence. Reasons: roster changes and absenteeism.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mandy Salomon | Mentia | 4156326872 | mandy@mentia.me |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2022 | Dec 20, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 11, 2022 | Dec 20, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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A Virtual Game Environment as a Behavioral Intervention for Alzheimer Disease
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| 6 weeks |
| 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. | 6 weeks |
| 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 | 6 weeks |
| Oakland |
| California |
| 94602 |
| United States |
| 26728933 | Background | Bourgeois J, Laye M, Lemaire J, Leone E, Deudon A, Darmon N, Giaume C, Lafont V, Brinck-Jensen S, Dechamps A, Konig A, Robert P. Relearning of Activities of Daily Living: A Comparison of the Effectiveness of Three Learning Methods in Patients with Dementia of the Alzheimer Type. J Nutr Health Aging. 2016 Jan;20(1):48-55. doi: 10.1007/s12603-016-0675-4. |
Subjects are the allocated caregivers of the primary participants (i.e., persons living with dementia residing in memory care communities) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | mean/standard deviation |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ADCS-ADL | Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL- Severe) Collected by survey questionnaire. The ADCS-ADL assesses the competence of patients with Alzheimer's Disease (AD) in basic and instrumental activities of daily living (ADLs).Completed by a caregiver in questionnaire format and 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. | Does not apply to this group | Mean | Standard Deviation | score on a scale |
|
| NPI-NH | The Neuropsychiatric Inventory - Nursing Home Version 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. Administered by a clinician/researcher as a structured interview with a caregiver. | Does not apply to this group | Mean | Standard Deviation | score on a scale |
|
| ADQ | 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. Questionnaire completed by caregivers. | Does not apply to this group | Mean | Standard Deviation | score on a scale |
|
| SCIDS | Sense of Competence in Dementia Care Staff 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. Completed by caregivers | Does not apply to this group | Mean | Standard Deviation | score on a scale |
|
| CBI | Copenhagen Burnout Inventory(CBI) The (CBI) is a 19-item survey that measures burnout in three areas: personal, work-related, and client-related. The total scale ranges from 0 to 300, with high scores indicating high levels of burnout. This inventory is self administered by caregivers. | Does not apply to this group | Mean | Standard Deviation | score on a scale |
|
|
|
|
| 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. | From twenty-four resident participant surveys, eight were excluded from analysis because surveys were a) not filled out or b) incomplete. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Professional Dementia Caregivers in Memory Care Communities | Subjects are caregivers of the primary participants, ie persons living with dementia | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|