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

Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care

The purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of Veterans with dementia.

Study Overview

• Status: Completed
• Conditions: Brain Diseases; Neurodegenerative Diseases; Dementia; Caregivers
• Intervention / Treatment: Behavioral: Education and Skill-Building Rehabilitation (ESBR); Other: Supplemental Education Materials

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1290
      • VA Palo Alto Health Care System, Palo Alto, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition; Education and Skill-Building Rehabilitation delivered in clinic	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 Names: ESBR
Experimental: Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition; Education and Skill-Building Rehabilitation delivered via video telehealth.	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 Names: ESBR
Active Comparator: Usual Care Condition; Usual Care plus supplemental paper education materials	Other: Supplemental Education Materials; Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in All-cause Mortality Status (Care Recipient)	Based on caregiver interview, care recipient mortality status will be ascertained	6-months post intervention

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Blake K Scanlon, PhD, VA Palo Alto Health Care System, Palo Alto, CA; Principal Investigator: Jennifer K Fairchild, PhD, VA Palo Alto Health Care System, Palo Alto, CA

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2014
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (Estimate): April 7, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Emergency Medical Services; Dementia; Stress, Psychological; Mortality; Caregivers; Neurodegenerative Diseases; Long-Term Care; Brain Diseases; Behavioral Symptoms; Cost of Illness; Vital Statistics; Residential Facilities
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Brain Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: E1240-W; 5IK2RX001240-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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