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Completed

NCT Number: NCT02106065

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ESBR

Supplemental Education Materials

Other

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

Primary outcomes

  1. Zarit Burden Inventory

    Time frame: change from baseline at 6-months post intervention

    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.

Secondary outcomes

  1. Center for Epidemiological Studies-Depression

    Time frame: change from baseline at 6-months

    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.

  2. Long-term Care Placement Status (Care Recipient)

    Time frame: 6-months post intervention

    Based on caregiver interview, permanent placement of the care recipient in LTC will be ascertained

  3. Change in All-cause Mortality Status (Care Recipient)

    Time frame: 6-months post intervention

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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Dementia Caregiver Rehabilitation: Enhancing Veteran and Family-Centered Care

Acronym: VACARES

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 7, 2014
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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