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

Dementia Clinical Trial

— VACARES  

Official title:

Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106065
• Other study ID #: E1240-W
• Secondary ID: 5IK2RX001240-02
• Status: Completed
• Phase: N/A
• Start date: February 21, 2014
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Caregivers
• Dementia
• Neurodegenerative Diseases

Intervention

Behavioral:
• 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.

Other:
• Supplemental Education Materials
Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	change from baseline at 6-months post intervention
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.	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	6-months post intervention
Secondary	Change in All-cause Mortality Status (Care Recipient)	Based on caregiver interview, care recipient mortality status will be ascertained	6-months post intervention