Brain Diseases, Caregivers, Dementia, Neurodegenerative Diseases
Conditions
Keywords
Dementia, Caregivers, Neurodegenerative Diseases, Brain Diseases, Cost of Illness, Stress, Psychological, Depression, Vital Statistics, Mortality, Behavioral Symptoms, Residential Facilities, Emergency Medical Services, Long-Term Care
Brief summary
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
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.
Interventions
BEHAVIORALEducation 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.
OTHERSupplemental Education Materials
Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Inventory | change from baseline at 6-months post intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiological Studies-Depression | change from baseline at 6-months | 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. |
| Long-term Care Placement Status (Care Recipient) | 6-months post intervention | Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained |
| Change in All-cause Mortality Status (Care Recipient) | 6-months post intervention | Based on caregiver interview, care recipient mortality status will be ascertained |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 11 |
| 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. | 15 |
| Total | 32 |
Baseline characteristics
| Characteristic | Usual Care | Total | ESBR-i | ESBR-v |
|---|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 10.9 | 68.6 years STANDARD_DEVIATION 9.53 | 71.0 years STANDARD_DEVIATION 7 | 69.8 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 20 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Female | 14 Participants | 22 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 10 Participants | 0 Participants | 9 Participants |
| Zarit Burden Inventory | 40.8 units on a scale STANDARD_DEVIATION 12 | 40.47 units on a scale STANDARD_DEVIATION 9.9 | 50.0 units on a scale STANDARD_DEVIATION 5.2 | 30.6 units on a scale STANDARD_DEVIATION 12.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 6 | 0 / 11 | 0 / 15 |
| other Total, other adverse events | 0 / 6 | 0 / 11 | 1 / 15 |
| serious Total, serious adverse events | 0 / 6 | 0 / 11 | 0 / 15 |
Outcome results
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.
Time frame: change from baseline at 6-months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESBR-i | Zarit Burden Inventory | 2.0 score on a scale | Standard Deviation 2.6 |
| ESBR-v | Zarit Burden Inventory | -0.4 score on a scale | Standard Deviation 5 |
| Usual Care | Zarit Burden Inventory | 1.6 score on a scale | Standard Deviation 3 |
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.
Time frame: change from baseline at 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESBR-i | Center for Epidemiological Studies-Depression | 2.0 score on a scale | Standard Deviation 6.9 |
| ESBR-v | Center for Epidemiological Studies-Depression | 0.1 score on a scale | Standard Deviation 3.3 |
| Usual Care | Center for Epidemiological Studies-Depression | -0.2 score on a scale | Standard Deviation 5.3 |
Secondary
Change in All-cause Mortality Status (Care Recipient)
Based on caregiver interview, care recipient mortality status will be ascertained
Time frame: 6-months post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESBR-i | Change in All-cause Mortality Status (Care Recipient) | 1 Participants |
| ESBR-v | Change in All-cause Mortality Status (Care Recipient) | 0 Participants |
| Usual Care | Change in All-cause Mortality Status (Care Recipient) | 1 Participants |
Secondary
Long-term Care Placement Status (Care Recipient)
Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained
Time frame: 6-months post intervention
Population: This data was not collected thus is not reported here.