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

This study is currently recruiting participants.
Verified June 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02106065
First Posted: April 7, 2014
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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 (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 VA Office of Research and Development:

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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Based on caregiver interview, care recipient mortality status will be ascertained


Estimated Enrollment: 150
Actual Study Start Date: February 21, 2014
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: December 31, 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, 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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106065


Contacts
Contact: Blake K Scanlon, PhD (650) 849-0481 Blake.Scanlon@va.gov
Contact: Jacob C Urbassik, BS (650) 849-0481 jacob.urbassik@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    650-849-0481    Blake.Scanlon@va.gov   
Contact: Jacob C Urbassik, BS    (650) 849-0481    jacob.urbassik@va.gov   
Principal Investigator: Blake K Scanlon, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Blake K Scanlon, PhD VA Palo Alto Health Care System, Palo Alto, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02106065     History of Changes
Other Study ID Numbers: E1240-W
5IK2RX001240-02 ( U.S. NIH Grant/Contract )
First Submitted: March 27, 2014
First Posted: April 7, 2014
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
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

Additional relevant MeSH terms:
Dementia
Brain Diseases
Neurodegenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders