Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04337021 |
Other study ID # |
IIR 18-290 |
Secondary ID |
018452020-009 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 28, 2020 |
Est. completion date |
March 31, 2024 |
Study information
Verified date |
May 2024 |
Source |
VA Office of Research and Development |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Unpaid informal caregivers (CGs), such as family and friends, who are also employed may be at
significant risk of experiencing burden and stress. This may be especially true for CGs who
provide care to care recipients coping with behavioral health issues associated with
conditions like depression, anxiety, post-traumatic stress disorder and traumatic brain
injury. Stress not only increases the CG's risk of workplace difficulties, illness, and poor
quality of life, but also impacts the CG's ability to provide care for the care recipient.
The primary aim of this randomized study is to examine the impact of a novel intervention,
Caregiver SOS (Self-Management of Stress), on CG distress and work performance and
productivity. Caregiver SOS is delivered by phone and offers evidence-based, work and CG role
performance-focused self-management counseling to employed CGs. Study findings will
ultimately shed light on whether a program that specifically addresses caregiving-work
balance is effective in improving CGs' wellbeing and work functioning and the quality of
Veterans' care.
Description:
Background: Research has shown that unpaid, informal caregivers (CGs), such as family and
friends, who are also employed may be at significant risk of experiencing burden and stress.
A recent national survey found that approximately 60% of employed CGs had significant
problems balancing work and caregiving. Stress not only increases the CG's risk of illness
and diminishes their quality of life; it also impacts the CG's ability to provide care for
the care recipient (CR) and overall relationship quality. Moreover, while work frequently
adds to the CG's stress, relinquishing work can create new stress for both the CG and CR,
particularly when it involves losses in resources such as income, benefits, social contacts
and/or respite from caregiving duties.
Specific Aims: The aims of this study are to, 1) determine the extent to which, relative to
usual care, a novel intervention providing evidence-based, telephonic CG/work stress
self-management counseling is related to changes in CG psychological distress and ability to
function effectively in work and CG roles, and 2) evaluate whether participation in the
intervention is related to CGs' overall wellbeing and CRs' health care utilization.
Methodology: The investigators will conduct a randomized controlled trial and compare
pre/post changes among 300 CGs allocated to the Caregiver SOS (for Self-Management of Stress)
program or usual care. CGs who, 1) care for Veterans diagnosed with depression, anxiety,
PTSD, and/or traumatic brain injury (TBI) and, 2) screen positive for clinically significant
distress and CG/work role difficulty will be recruited to participate from two VA Medical
Centers and their affiliated outpatient clinics. A novel intervention, Caregiver SOS includes
6, 1-hour telephonic sessions with a care manager. Usual care will consist of 1 telephonic
session with a care manager. Primary and secondary outcomes will be pre-post change in CG
distress and work functioning, respectively. Additional CG and CR outcomes (i.e., physical
mental and interpersonal functioning) also will be measured and analyzed. CRs' VA health
utilization data will be extracted from clinical patient records and non-VA health
utilization data will be collected via CG self-report. Intent to treat analysis using mixed
effects models will be used to test the study hypotheses. The investigators anticipate that
CGs in the intervention arm will show significantly greater improvements in outcomes compared
to those in usual care.