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Caregiver Self-Management of Stress (Caregiver SOS)

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ClinicalTrials.gov Identifier: NCT04337021
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
The VA Western New York Healthcare System
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE April 3, 2020
First Posted Date  ICMJE April 7, 2020
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE December 28, 2020
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
K10 Psychological Distress Scale [ Time Frame: 9 months ]
Global measure of psychological distress
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
C-WLQ [ Time Frame: 9 months ]
25-item measure capturing the extent to which caregiving has impacted work performance and productivity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caregiver Self-Management of Stress
Official Title  ICMJE Caregiver SOS: An Intervention for Employed Caregivers
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 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Caregiver Distress
  • Job Stress
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Caregiver SOS
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Shahrzad Mavandadi, PhD (215) 823-5957 Shahrzad.Mavandadi@va.gov
Contact: Laura O Wray, PhD (716) 862-8598 Laura.Wray@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04337021
Other Study ID Numbers  ICMJE IIR 18-290
01845 ( Other Identifier: CMCVAMC IRB )
2020-009 ( Other Identifier: VAWNYHS IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE The VA Western New York Healthcare System
Investigators  ICMJE
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
PRS Account VA Office of Research and Development
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP