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| ID | Type | Description | Link |
|---|---|---|---|
| 5IK2RX001240-02 | U.S. NIH Grant/Contract | View source |
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The purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of Veterans with dementia.
According to VA estimates, nearly 500,000 Veterans suffer from dementia. There is currently no cure for dementia. Ultimately, dementia will have a large impact on quality of life in Veterans and families, lead to expensive nursing home placement, and decrease life expectancy for patients and family caregivers. The experience of high burden in a caregiver for a Veteran with dementia increases the likelihood of permanent nursing home placement and can separate Veterans from their families. To address the high burden of caring for a Veteran with dementia, the investigators aim to study the effect of a rehabilitative intervention for family caregivers of Veterans with dementia. This novel approach will use video technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition | Experimental | Education and Skill-Building Rehabilitation delivered in clinic |
|
| Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition | Experimental | Education and Skill-Building Rehabilitation delivered via video telehealth. |
|
| Usual Care Condition | Active Comparator | Usual Care plus supplemental paper education materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and Skill-Building Rehabilitation (ESBR) | Behavioral | ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. |
| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Inventory | The Zarit Burden Inventory is a self-report measure of caregiver burden. Higher scores on this assessment indicate greater levels of caregiver burden. Potential scores range from 0-88 with higher scores indicating more severe burden. | change from baseline at 6-months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiological Studies-Depression | change in caregiver depressive symptoms as measured by the Center for Epidemiological Studies-Depression (CES-D). Scores on the CES-D can range from 0-60 with higher scores suggesting greater depressive symptomatology. | change from baseline at 6-months |
| Long-term Care Placement Status (Care Recipient) |
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Inclusion Criteria:
Inclusion criteria -- Participants must:
Exclusion Criteria:
Exclusion criteria -- Potential participants will be screened and excluded for:
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| Name | Affiliation | Role |
|---|---|---|
| Blake K Scanlon, PhD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Jennifer K Fairchild, PhD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ESBR-i | Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. |
| FG001 | ESBR-v | Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. |
| FG002 | Usual Care | Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESBR-i | Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. |
| 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 | Zarit Burden Inventory | The Zarit Burden Inventory is a self-report measure of caregiver burden. Higher scores on this assessment indicate greater levels of caregiver burden. Potential scores range from 0-88 with higher scores indicating more severe burden. | Posted | Mean | Standard Deviation | score on a scale | change from baseline at 6-months post intervention |
|
24 Months
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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 | ESBR-i | Education and Skill-Building Rehabilitation (in-clinic) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kaci Fairchild | VA Palo Alto Health Care System | 6504935000 | 63432 | jenniferkaci.fairchild@va.gov |
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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 | Jun 3, 2020 | Jun 3, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D019636 | Neurodegenerative Diseases |
| D001927 | Brain Diseases |
| D013315 | Stress, Psychological |
| D003863 | Depression |
| D001526 | Behavioral Symptoms |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
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| Supplemental Education Materials | Other | Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia. |
|
Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained |
| 6-months post intervention |
| Change in All-cause Mortality Status (Care Recipient) | Based on caregiver interview, care recipient mortality status will be ascertained | 6-months post intervention |
| BG001 | ESBR-v | Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. |
| BG002 | Usual Care | Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Zarit Burden Inventory | The Zarit Burden Inventory is a self-report measure of caregiver burden. Scores range from 0-88 with higher scores indicating more severe burden. | Mean | Standard Deviation | units on a scale |
|
| ESBR-v |
Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. |
| OG002 | Usual Care | Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia. |
|
|
| Secondary | Center for Epidemiological Studies-Depression | change in caregiver depressive symptoms as measured by the Center for Epidemiological Studies-Depression (CES-D). Scores on the CES-D can range from 0-60 with higher scores suggesting greater depressive symptomatology. | Posted | Mean | Standard Deviation | score on a scale | change from baseline at 6-months |
|
|
|
| Secondary | Long-term Care Placement Status (Care Recipient) | Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained | This data was not collected thus is not reported here. | Posted | 6-months post intervention |
|
|
| Secondary | Change in All-cause Mortality Status (Care Recipient) | Based on caregiver interview, care recipient mortality status will be ascertained | Posted | Count of Participants | Participants | 6-months post intervention |
|
|
|
| 2 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | ESBR-v | Education and Skill-Building Rehabilitation (over video telehealth) Education and Skill-Building Rehabilitation (ESBR): ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Usual Care | Usual Care plus supplemental paper education materials Supplemental Education Materials: Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia. | 0 | 15 | 0 | 15 | 1 | 15 |
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| D001519 | Behavior |