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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02106065
First received: March 27, 2014
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Dementia
Caregivers
Neurodegenerative Diseases
Brain Diseases
Behavioral: Education and Skill-Building Rehabilitation (ESBR)
Other: Supplemental Education Materials
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • change in caregiver quality of life [ Time Frame: baseline; change from baseline at 6-months, 12-months, and 24-months post intervention ] [ Designated as safety issue: No ]
    Zarit Burden Interview


Secondary Outcome Measures:
  • change in caregiver depressive symptoms [ Time Frame: baseline; change from baseline at 6-months, 12-months, and 24-months post intervention ] [ Designated as safety issue: No ]
    Center for Epidemiological Studies-Depression

  • change in community tenure (care recipient) [ Time Frame: baseline; change from baseline at 6-months, 12-months, and 24-months post intervention ] [ Designated as safety issue: No ]
    Based on caregiver interview and available medical records, community tenure (i.e., amount of time spent living in the community and not hospitalized or placed in a facility) and number of incidents leading to non-community status will be ascertained.

  • change in long-term care placement status (care recipient) [ Time Frame: 6-months, 12-months, and 24-months post intervention ] [ Designated as safety issue: No ]
    Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained

  • change in all-cause mortality status (care recipient) [ Time Frame: 6-months, 12-months, and 24-months post intervention ] [ Designated as safety issue: No ]
    Based on caregiver interview, care recipient mortality status will be ascertained


Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESBR-i
Education and Skill-Building Rehabilitation (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 Name: ESBR
Experimental: ESBR-v
Education and Skill-Building Rehabilitation (over 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 Name: ESBR
Active Comparator: UC
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.

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, we aim to study the effect of a rehabilitative intervention for family caregivers of Veterans with dementia. Our novel approach will use video technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106065

Contacts
Contact: Blake K Scanlon, PhD (650) 493-5000 ext 65316 Blake.Scanlon@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Blake K Scanlon, PhD    650-493-5000 ext 65316    Blake.Scanlon@va.gov   
Principal Investigator: Blake K. Scanlon, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Blake K. Scanlon, PhD VA Palo Alto Health Care System, Palo Alto, CA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02106065     History of Changes
Other Study ID Numbers: E1240-W, 1 IK2 RX001240
Study First Received: March 27, 2014
Last Updated: April 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Emergency Medical Services
Dementia
Caregivers
Neurodegenerative Diseases
Brain Diseases
Cost of Illness
Stress, Psychological
Depression
Vital Statistics
Mortality
Behavioral Symptoms
Residential Facilities
Long-Term Care

Additional relevant MeSH terms:
Brain Diseases
Dementia
Neurodegenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014