VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care

Conditions
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Dementia, Caregivers, Neurodegenerative Diseases, Brain Diseases

Intervention / Treatment
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* Behavioral: Education and Skill-Building Rehabilitation (ESBR)
* Other: Supplemental Education Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria -- Participants must: be adults (age 18) report distress associated with being the primary caregiver for a Veteran family member with all-cause dementia reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined provide at least one hour of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members, etc.) be proficient in spoken and written English be capable of providing informed consent Exclusion Criteria: Exclusion criteria -- Potential participants will be screened and excluded for: current or lifetime history of any psychiatric disorder with psychotic features prominent suicidal or homicidal ideation having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation diagnosis of probable or possible dementia a Telephone Cognitive Screen score of < 20 participation in another caregiver intervention within the past year lack of regular access to a telephone illness that would prevent 24 months of study participation planned transfer of care receiver to another caregiver or nursing home within 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition<br>Education and Skill-Building Rehabilitation delivered in clinic | Behavioral: Education and Skill-Building Rehabilitation (ESBR)<br>* 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.<br>* Other names: ESBR;|
| Experimental: Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition<br>Education and Skill-Building Rehabilitation delivered via video telehealth. | Behavioral: Education and Skill-Building Rehabilitation (ESBR)<br>* 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.<br>* Other names: ESBR;|
| Active Comparator: Usual Care Condition<br>Usual Care plus supplemental paper education materials | Other: Supplemental Education Materials<br>* Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mortality, Cost of Illness, Dementia, Caregivers, Neurodegenerative Diseases, Brain Diseases, Stress, Psychological, Depression, Vital Statistics, Behavioral Symptoms, Residential Facilities, Emergency Medical Services, Long-Term Care