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| ID | Type | Description | Link |
|---|---|---|---|
| 1I21RX001710 | U.S. NIH Grant/Contract | View source |
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To address the high burden of caring for a Veteran with dementia, the investigators propose to study the effect of a low-cost, rehabilitative intervention for family caregivers of Veterans with dementia. The investigators' novel approach will use mobile media technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers. If this rehabilitative intervention proves successful, it may represent an approach to Veteran and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.
The proposed project studies the effects of an education and skill-building rehabilitation intervention, designed to be low-cost and clinically translatable through mobile media devices (i.e., tablets), on family caregivers of Veterans with dementia. Intervention effects will be examined longitudinally at baseline and 3 months post-intervention.
Advanced statistical techniques will be used to determine the impact of the intervention on: quality of life in caregivers of Veterans with dementia (Aim 1), perceived stress and depressive symptoms in caregivers (Aim 2), and socialization and engagement in pleasant activities in caregivers (Aim 3).
If this rehabilitative intervention proves successful, it may represent an approach to Veteran- and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Media Education and Skill-Building Rehabilitation Int | Experimental | The investigators' ESBR-m intervention consists of four, 90-minute group (= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session. |
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| Usual Care | Active Comparator | Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and Skill Building Rehabilitation-mobile (ESBR-m) | Behavioral | Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Zarit Burden Interview (ZBI) at 4 Months | The Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden. Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers. Scores for each item range from 0 (never) to 4 (nearly always) on questions such as "Do you feel embarrassed by your relative's behavior?." Total scores are calculated by summing all responses and range from 0-88. A higher score is indicative of a worse outcome. | Baseline, 4 month follow-up |
| Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months | The Center for Epidemiological Studies-Depression (CES-D) is a 20-item, self-report measure of frequency of depressive symptoms over a one week period. The CES-D is frequently used to assess depression in dementia caregivers and has been shown to be sensitive to changes in caregiver depression post intervention. Scores for each item range from 0 (rarely or none of the time) to 3 (most or all of the time), with some items reverse coded. Total scores are calculated by summing all responses and range from 0-60. A higher score is indicative of a worse outcome. | Baseline, 4 month follow-up |
| Change From Baseline Perceived Stress Scale (PSS) at 4 Months | The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. We use a 14 item version of the PSS with a minimum score of 0 and a maximum score of 56. Lower values indicate lower perceived stress while higher values indicate higher perceived stress. | Baseline, 4 month follow-up |
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Inclusion Criteria:
-- Participants must:
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 |
| 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 | Mobile Media Education and Skill-Building Rehabilitation Int | The investigators' ESBR-m intervention consists of four, 90-minute group (<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session. Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session. |
| FG001 | Usual Care | Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Media Education and Skill-Building Rehabilitation Int | The investigators' ESBR-m intervention consists of four, 90-minute group (<= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session. Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session. |
| 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 | Change From Baseline Zarit Burden Interview (ZBI) at 4 Months | The Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden. Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers. Scores for each item range from 0 (never) to 4 (nearly always) on questions such as "Do you feel embarrassed by your relative's behavior?." Total scores are calculated by summing all responses and range from 0-88. A higher score is indicative of a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 month follow-up |
|
4 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 | Mobile Media Education and Skill-Building Rehabilitation Int | The investigators' ESBR-m intervention consists of four, 90-minute group (= 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session. Education and Skill Building Rehabilitation-mobile (ESBR-m): Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Blake Scanlon | VA Palo Alto Health Care System | 6504935000 | 65316 | blake.scanlon@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2014 | Apr 23, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 21, 2014 | Apr 23, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| Usual Care (UC) | Behavioral | Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). |
|
| BG001 | Usual Care | Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Usual Care | Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). |
|
|
| Primary | Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months | The Center for Epidemiological Studies-Depression (CES-D) is a 20-item, self-report measure of frequency of depressive symptoms over a one week period. The CES-D is frequently used to assess depression in dementia caregivers and has been shown to be sensitive to changes in caregiver depression post intervention. Scores for each item range from 0 (rarely or none of the time) to 3 (most or all of the time), with some items reverse coded. Total scores are calculated by summing all responses and range from 0-60. A higher score is indicative of a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 month follow-up |
|
|
|
| Primary | Change From Baseline Perceived Stress Scale (PSS) at 4 Months | The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. We use a 14 item version of the PSS with a minimum score of 0 and a maximum score of 56. Lower values indicate lower perceived stress while higher values indicate higher perceived stress. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 month follow-up |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Usual Care | Usual Care (plus supplemental educational materials). Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). Usual Care (UC): Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss"). | 0 | 8 | 0 | 8 | 0 | 8 |
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |