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

Not Applicable

Completed

• Conditions: Dementia; Neurodegenerative Diseases; Brain Diseases; Caregivers
• Interventions: Behavioral: Education and Skill-Building Rehabilitation (ESBR); Other: Supplemental Education Materials

• Registration Number: NCT02106065
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study Start: 2014-02-21
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Results First Submitted: 2020-12-10
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Results First Posted: 2021-08-13
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition	Education and Skill-Building Rehabilitation (ESBR)	Education and Skill-Building Rehabilitation delivered via video telehealth.
Usual Care Condition	Supplemental Education Materials	Usual Care plus supplemental paper education materials
In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition	Education and Skill-Building Rehabilitation (ESBR)	Education and Skill-Building Rehabilitation delivered in clinic

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

VA Palo Alto Health Care System, Palo Alto, CA; 🇺🇸 Palo Alto, California, United States