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

NCT02106065 | Completed Results

• 2 other identifiers: E1240-W5IK2RX001240-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Center for Epidemiological Studies-Depression

  change from baseline at 6-months

• Long-term Care Placement Status (Care Recipient)

  6-months post intervention

• Change in All-cause Mortality Status (Care Recipient)

  6-months post intervention

Study Arms (3)

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

EXPERIMENTAL

Education and Skill-Building Rehabilitation delivered in clinic

Behavioral: Education and Skill-Building Rehabilitation (ESBR)

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

EXPERIMENTAL

Education and Skill-Building Rehabilitation delivered via video telehealth.

Behavioral: Education and Skill-Building Rehabilitation (ESBR)

Usual Care Condition

ACTIVE COMPARATOR

Usual Care plus supplemental paper education materials

Other: Supplemental Education Materials

Interventions

Education and Skill-Building Rehabilitation (ESBR) 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.

Also known as: ESBR

Education and Skill-Building Rehabilitation over Video (ESBR-V) Condition; In-person Education and Skill-Building Rehabilitation (ESBR-i) Condition

Supplemental Education Materials OTHER

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

Usual Care Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Dementia; Neurodegenerative Diseases; Brain Diseases; Stress, Psychological; Depression; Behavioral Symptoms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Kaci Fairchild
• Organization: VA Palo Alto Health Care System

jenniferkaci.fairchild@va.gov

6504935000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 7, 2014
• Study Start: February 21, 2014
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 13, 2021
• Results First Posted: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)