- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337021
Caregiver Self-Management of Stress (Caregiver SOS)
Caregiver SOS: An Intervention for Employed Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shahrzad Mavandadi, PhD
- Phone Number: (215) 823-5957
- Email: Shahrzad.Mavandadi@va.gov
Study Contact Backup
- Name: Laura O Wray, PhD
- Phone Number: (716) 862-8598
- Email: laura.wray@va.gov
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14215-1129
- Recruiting
- VA Western New York Healthcare System, Buffalo, NY
-
Contact:
- Laura O Wray, PhD
- Phone Number: 716-862-8598
- Email: laura.wray@va.gov
-
Contact:
- Shahrzad Mavandadi, PhD
- Phone Number: (215) 823-5957
- Email: Shahrzad.Mavandadi@va.gov
-
Principal Investigator:
- Laura O Wray, PhD
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104-4551
- Recruiting
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
-
Contact:
- Shahrzad Mavandadi, PhD
- Phone Number: 215-823-5957
- Email: Shahrzad.Mavandadi@va.gov
-
Principal Investigator:
- Amy W Helstrom, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Veteran receives care at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC), VA Western New York Healthcare System (VAWNYHS), or affiliated community-based outpatient clinics
- Veteran and CG are 18 years of age or older
- Veteran and CG are community dwelling
- Veteran has a confirmed diagnosis of depressive disorder, generalized anxiety disorder, PTSD, and/or TBI (per medical chart/provider report)
CG is a relative or significant other who endorses that s/he assists the Veteran care recipient (CR) with two or more instrumental activities of daily living (IADLs). IADLS include:
- housework
- managing finances
- arranging/providing transportation (e.g., to medical appointments and community services)
- grocery shopping
- preparing meals
- health management and maintenance (e.g., giving medications, minimizing exposure and response to stress triggers)
- arranging for and/or supervising the delivery of services for assistance with everyday activities
- CG is employed
- CG screens positive for at least mild-moderate distress
- CG screens positive for at least moderate work role difficulty due to caregiving
- CG is willing and able to provide informed consent
Exclusion Criteria:
- CG cognitive, hearing, visual, or other physical impairments leading to difficulty with informed consent process, assessment, or participation in intervention visits
- CG unable to speak or read English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Caregiver SOS
SOS care is brief, telephonic care (6 one-hour sessions over 3-4 months) tailored to the CG's needs, preferences, and priorities.
SOS care addresses both work and caregiving-related stress.
The five pillars of behavior change in SOS care are: 1) knowledge of work and CG stress; 2) stress management skills and abilities; 3) supports and resources; 4) confidence and motivation to modify stress; and 5) work and CG-focused problem-solving skills.
The pillars are addressed through seven modules.
In six sessions, the CM will cover each module at least once.
SOS care involves an ongoing process of formulating self-management goals and action plans and preparing CGs to succeed in implementing them.
Addressing both work and caregiving contexts, CMs will educate CGs about stress.
CMs introduce strategies for self-managing stress and collaboratively design experiments to test these strategies.
The CG's progress is monitored to identify strategies that effectively achieve self management goals.
|
SOS care is brief, telephonic care (6 one-hour sessions over 3-4 months) tailored to the CG's needs, preferences, and priorities.
SOS care addresses both work and caregiving stress.
The five pillars of behavior change in SOS care are: 1) knowledge of work and CG stress; 2) stress management skills and abilities; 3) supports and resources; 4) confidence and motivation to modify stress; and 5) work and CG-focused problem-solving skills.
The pillars are addressed through seven modules.
In six sessions, the CM will cover each module at least once.
SOS care involves an ongoing process of formulating self-management goals and action plans and preparing CGs to succeed in implementing them.
Addressing both work and caregiving contexts, CMs will educate CGs about stress.
CMs introduce strategies for self-managing stress and collaboratively design experiments to test these strategies.
The CG's progress is monitored to identify strategies that effectively achieve self management goals.
|
No Intervention: Usual Care
CGs in this arm will be contacted telephonically once by a CM.
After a brief needs assessment, the CM will provide contact information for appropriate VA (e.g., local CSP clinicians) and non-VA community resources/services.
CGs will be sent brochures for the national VA CSP.
Information on both the program's website (which includes links to training, education, resources, and outreach programs for CGs) and the national CG hotline number will be included in the mailed packet.
After this initial contact, CGs in this group will only be contacted again 4 and 9 months after baseline for administration of follow-up research assessments.
CGs will be encouraged to seek medical, psychological, social support, and social services that are available to them through VAMCs or any other non-VA/community source.
CGs in the SOS group will be offered similar information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10-item Kessler Psychological Distress Scale (K10)
Time Frame: 9 months
|
Global measure of psychological distress; scores range from 10-50, with higher scores indicating worse outcomes (higher levels of distress)
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver Work Limitations Questionnaire (C-WLQ)
Time Frame: 9 months
|
25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty)
|
9 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laura O Wray, PhD, VA Western New York Healthcare System, Buffalo, NY
- Principal Investigator: Amy W Helstrom, PhD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 18-290
- 01845 (Other Identifier: CMCVAMC IRB)
- 2020-009 (Other Identifier: VAWNYHS IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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