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

Primary Purpose

Dementia, Caregivers, Neurodegenerative Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and Skill-Building Rehabilitation (ESBR)
Supplemental Education Materials
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition

Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition

Usual Care Condition

Arm Description

Education and Skill-Building Rehabilitation delivered in clinic

Education and Skill-Building Rehabilitation delivered via video telehealth.

Usual Care plus supplemental paper education materials

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Long-term Care Placement Status (Care Recipient)
Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained
Change in All-cause Mortality Status (Care Recipient)
Based on caregiver interview, care recipient mortality status will be ascertained

Full Information

First Posted
March 27, 2014
Last Updated
July 20, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02106065
Brief Title
VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers
Acronym
VACARES
Official Title
Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 21, 2014 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition
Arm Type
Experimental
Arm Description
Education and Skill-Building Rehabilitation delivered in clinic
Arm Title
Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition
Arm Type
Experimental
Arm Description
Education and Skill-Building Rehabilitation delivered via video telehealth.
Arm Title
Usual Care Condition
Arm Type
Active Comparator
Arm Description
Usual Care plus supplemental paper education materials
Intervention Type
Behavioral
Intervention Name(s)
Education and Skill-Building Rehabilitation (ESBR)
Other Intervention Name(s)
ESBR
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Supplemental Education Materials
Intervention Description
Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
Primary Outcome Measure Information:
Title
Zarit Burden Inventory
Description
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
Secondary Outcome Measure Information:
Title
Center for Epidemiological Studies-Depression
Description
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
Title
Long-term Care Placement Status (Care Recipient)
Description
Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained
Time Frame
6-months post intervention
Title
Change in All-cause Mortality Status (Care Recipient)
Description
Based on caregiver interview, care recipient mortality status will be ascertained
Time Frame
6-months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blake K Scanlon, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer K Fairchild, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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