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

NCT ID: NCT02106065

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-21
• Study Completion Date: 2019-09-30

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.

Conditions

Dementia; Caregivers; Neurodegenerative Diseases; Brain Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Education and Skill-Building Rehabilitation delivered in clinic

Group Type: EXPERIMENTAL

Education and Skill-Building Rehabilitation (ESBR)

Intervention Type: BEHAVIORAL

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.

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

Education and Skill-Building Rehabilitation delivered via video telehealth.

Group Type: EXPERIMENTAL

Education and Skill-Building Rehabilitation (ESBR)

Intervention Type: BEHAVIORAL

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.

Usual Care Condition

Usual Care plus supplemental paper education materials

Group Type: ACTIVE_COMPARATOR

Supplemental Education Materials

Intervention Type: OTHER

Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.

Interventions

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.

Intervention Type: BEHAVIORAL

Supplemental Education Materials

Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.

Intervention Type: OTHER

Other Intervention Names

ESBR

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Blake K Scanlon, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Jennifer K Fairchild, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5IK2RX001240-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

E1240-W

Identifier Type: -

Identifier Source: org_study_id