Caregiver Self-Management of Stress (Caregiver SOS)
|
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. |
| ClinicalTrials.gov Identifier: NCT04337021 |
|
Recruitment Status :
Recruiting
First Posted : April 7, 2020
Last Update Posted : January 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Caregiver Distress Job Stress | Behavioral: Caregiver SOS | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Caregiver SOS is delivered by phone and offers evidence-based, work and CG role performance-focused self-management counseling to employed CGs. The program includes 6, 1-hour telephonic sessions with a care manager. |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Caregiver SOS: An Intervention for Employed Caregivers |
| Actual Study Start Date : | December 28, 2020 |
| Estimated Primary Completion Date : | March 31, 2024 |
| Estimated Study Completion Date : | March 31, 2024 |
| 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.
|
Behavioral: 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 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.
|
- 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)
- 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)
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, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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): NCT04337021
| Contact: Shahrzad Mavandadi, PhD | (215) 823-5957 | Shahrzad.Mavandadi@va.gov | |
| Contact: Laura O Wray, PhD | (716) 862-8598 | Laura.Wray@va.gov |
| United States, New York | |
| VA Western New York Healthcare System, Buffalo, NY | Recruiting |
| Buffalo, New York, United States, 14215 | |
| Contact: Laura O Wray, PhD 716-862-8598 Laura.Wray@va.gov | |
| Contact: Shahrzad Mavandadi, PhD (215) 823-5957 Shahrzad.Mavandadi@va.gov | |
| Principal Investigator: Laura O Wray, PhD | |
| United States, Pennsylvania | |
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Shahrzad Mavandadi, PhD 215-823-5957 Shahrzad.Mavandadi@va.gov | |
| Principal Investigator: Shahrzad Mavandadi, PhD | |
| Principal Investigator: | Shahrzad Mavandadi, PhD | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | |
| Principal Investigator: | Laura O Wray, PhD | VA Western New York Healthcare System, Buffalo, NY |
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT04337021 |
| Other Study ID Numbers: |
IIR 18-290 01845 ( Other Identifier: CMCVAMC IRB ) 2020-009 ( Other Identifier: VAWNYHS IRB ) |
| First Posted: | April 7, 2020 Key Record Dates |
| Last Update Posted: | January 5, 2021 |
| Last Verified: | December 2020 |
| 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 |
|
psychological stress family caregivers work stress spouse caregivers life stress |
|
Occupational Stress Occupational Diseases Stress, Psychological Behavioral Symptoms |