Clinical trial NCT02106065: VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers
Official title: Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Caregivers
Neurodegenerative Diseases
Brain Diseases
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-04-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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.

Eligibility criteria: 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

Primary outcomes:
measure: Zarit Burden Inventory
timeFrame: change from baseline at 6-months post intervention
Secondary outcomes:
measure: Center for Epidemiological Studies-Depression
timeFrame: change from baseline at 6-months
measure: Long-term Care Placement Status (Care Recipient)
timeFrame: 6-months post intervention
measure: Change in All-cause Mortality Status (Care Recipient)
timeFrame: 6-months post intervention
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Blake K Scanlon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Jennifer K Fairchild, PhD
role: PRINCIPAL_INVESTIGATOR
References: