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Our study is designed to help caregivers of someone with Alzheimer's Disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.
The goal of this study is to develop and evaluate the Caring Response mobile app, containing a training that builds skills and stimulates practice. The investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. The research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Patient Behavioral Response Training | Experimental | Caring Response mobile app with a behavioral training. |
|
| Educational Training | Active Comparator | Traditional educational program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caring Response App | Behavioral | Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revised Memory and Behavior Problems Checklist | This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome. | 3 months |
| Center for Epidemiological Studies Depression Scale | The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome. | 3 months |
| Perceived Stress Scale | The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Kajiyama, MS | Photozig, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Photozig, Inc. | Mountain View | California | 94035-0128 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Patient Behavioral Response Training | Caring Response mobile app with a behavioral training. Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training. |
| FG001 | Educational Training | Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Patient Behavioral Response Training | Caring Response mobile app with a behavioral training. Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training. |
| BG001 | Educational Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Revised Memory and Behavior Problems Checklist | This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
3 months
The definitions are the same as the ones from clinicaltrials.gov
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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 | Virtual Patient Behavioral Response Training | Caring Response mobile app with a behavioral training. Caring Response App: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruno Kajiyama | Photozig, Inc. | 6506947496 | info@photozig.com |
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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 | May 13, 2022 | May 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Traditional Educational/Resources Program | Behavioral | Participants will receive a traditional educational/resources program, containing a workbook and online resources. |
|
Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Educational Training | Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources. |
|
|
| Primary | Center for Epidemiological Studies Depression Scale | The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Primary | Perceived Stress Scale | The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Educational Training | Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources. | 0 | 78 | 0 | 78 | 0 | 78 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |