Ignite Creation Date:
2024-05-06 @ 2:29 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04337021
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2020-04-03
Brief Title:
Caregiver Self-Management of Stress
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Caregiver SOS An Intervention for Employed Caregivers
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Caregiver SOS
Brief 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 CGs risk of workplace difficulties illness and poor quality of life but also impacts the CGs 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
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 CGs risk of illness and diminishes their quality of life it also impacts the CGs ability to provide care for the care recipient CR and overall relationship quality Moreover while work frequently adds to the CGs 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 andor 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 CGwork 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 prepost 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 andor traumatic brain injury TBI and 2 screen positive for clinically significant distress and CGwork 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 ie 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
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 CGwork 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 prepost 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 andor traumatic brain injury TBI and 2 screen positive for clinically significant distress and CGwork 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01845 | OTHER | None | None |
| 2020-009 | OTHER | VAWNYHS IRB | None |