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Caring Light is designed to help caregivers of someone with Alzheimer's Disease and related dementia to cope with the difficulties related to caregiving, reduce stress, and improve quality of life.
The goals of this study are to evaluate materials related to dementia caregiving and how to cope with difficult situations faced by caregivers. Based on this research, the investigators are developing the new Caring Light mobile app with a self-paced program to enhance the quality of life, a curriculum that incorporates relaxation techniques, and coping skills training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caring Light Training | Experimental | Caring Light mobile app with coping skills 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 Light mobile app containing the coping skills training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 | Caring Light Training | Caring Light mobile app with coping skills training. Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills 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 | Caring Light Training | Caring Light mobile app with coping skills training. Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills 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 | 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. | Caregivers with full data for the CES-D instrument were included in the outcomes analysis. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
3 months
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 | Caring Light Training | Caring Light mobile app with coping skills training. Caring Response App: Participants will receive the Caring Light mobile app containing the coping skills 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 8, 2022 | May 9, 2022 | 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 |
|
| Educational Training |
Traditional educational program. Traditional Educational/Resources Program: Participants will receive a traditional educational/resources program, containing a workbook and online resources. |
|
|
| 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. | Caregivers with full data for the "Revised Memory and Behavior Problems Checklist" were included in the outcomes analysis. | 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. | Caregivers with full data for the "Perceived Stress Scale" were included in the outcomes analysis. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
| 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 | 82 | 0 | 82 | 0 | 82 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |