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Caregiver Self-Management of Stress (Caregiver SOS)

Primary Purpose

Caregiver Distress, Job Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caregiver SOS
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Distress focused on measuring psychological stress, family caregivers, work stress, spouse caregivers, life stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Western New York Healthcare System, Buffalo, NYRecruiting
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Caregiver SOS

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

10-item Kessler Psychological Distress Scale (K10)
Global measure of psychological distress; scores range from 10-50, with higher scores indicating worse outcomes (higher levels of distress)

Secondary Outcome Measures

Caregiver Work Limitations Questionnaire (C-WLQ)
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)

Full Information

First Posted
April 3, 2020
Last Updated
November 16, 2022
Sponsor
VA Office of Research and Development
Collaborators
The VA Western New York Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04337021
Brief Title
Caregiver Self-Management of Stress
Acronym
Caregiver SOS
Official Title
Caregiver SOS: An Intervention for Employed Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
The VA Western New York Healthcare System

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Distress, Job Stress
Keywords
psychological stress, family caregivers, work stress, spouse caregivers, life stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caregiver SOS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caregiver SOS
Intervention Description
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.
Primary Outcome Measure Information:
Title
10-item Kessler Psychological Distress Scale (K10)
Description
Global measure of psychological distress; scores range from 10-50, with higher scores indicating worse outcomes (higher levels of distress)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Caregiver Work Limitations Questionnaire (C-WLQ)
Description
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)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahrzad Mavandadi, PhD
Phone
(215) 823-5957
Email
Shahrzad.Mavandadi@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Laura O Wray, PhD
Phone
(716) 862-8598
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahrzad Mavandadi, PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura O Wray, PhD
Organizational Affiliation
VA Western New York Healthcare System, Buffalo, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Western New York Healthcare System, Buffalo, NY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura O Wray, PhD
Phone
716-862-8598
First Name & Middle Initial & Last Name & Degree
Shahrzad Mavandadi, PhD
Phone
(215) 823-5957
Email
Shahrzad.Mavandadi@va.gov
First Name & Middle Initial & Last Name & Degree
Laura O Wray, PhD
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahrzad Mavandadi, PhD
Phone
215-823-5957
Email
Shahrzad.Mavandadi@va.gov
First Name & Middle Initial & Last Name & Degree
Shahrzad Mavandadi, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Caregiver Self-Management of Stress

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