Integrating Caregiver Support Into MS Care
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Caregivers, Activities of Daily Living
Eligibility Criteria
Inclusion Criteria:
- Veteran being seen in MS clinic at Memphis VA
- Veteran ambulatory
- Caregiver/care partner who agrees to participate
Exclusion Criteria:
- None
Sites / Locations
- Memphis VA Medical Center, Memphis, TN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Outcomes
Primary Outcome Measures
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Caregiver primary outcome. PHQ-9, range 0-27, lower better
Burden Measured With the Zarit Burden Inventory
Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better
Number of Patient MS Problems
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
Bother With Patient MS Problems
Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
Secondary Outcome Measures
Full Information
NCT ID
NCT02835677
First Posted
July 12, 2016
Last Updated
May 21, 2019
Sponsor
VA Office of Research and Development
Collaborators
Memphis VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02835677
Brief Title
Integrating Caregiver Support Into MS Care
Official Title
Integrating Caregiver Support Into MS Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 7, 2016 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Memphis VA Medical Center
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
No
5. Study Description
Brief Summary
With loss of mobility in multiple sclerosis (MS) comes an increase in amount and types of caregiver assistance, with a concomitant increase in burden for the caregiver. In fact, effect on caregiver burden can be seen as a potential indicator of the efficacy of MS management, suggesting that the caregiver is an appropriate and independent target for MS therapeutic strategies.
MS patients report difficulty implementing and continuing with home exercise, mobility, and walking programs. This feasibility study will test integration of a successful behavioral caregiving intervention into clinical practice to improve functioning of Veterans with multiple sclerosis (MS) and their Caregivers. Caregivers of Veterans with MS will receive a behavioral caregiver intervention designed to address caregiver coping and management of patient concerns, with special focus on patient mobility and walking. A pre-post intervention design will compare outcomes for Veterans and Caregivers.
For Veterans, the intervention will target Caregiver participation in home-based Veteran mobility activities. MS Caregivers report high burden, stress, and depression involved in caring for their loved ones, especially as mobility declines and these outcomes are related to physical and emotional health status of the patient. For Caregivers, the intervention will focus on improving Caregiver coping and on managing MS-related problems. Outcomes for both will be measured at baseline, 3 months, and 6 months.
Study Objectives include:
Test whether a caregiver intervention can be integrated into an MS clinical setting.
Determine whether Caregiver outcomes are improved (depression, burden, anxiety, and number of Veteran MS problems and safety alerts reported).
Determine whether Veteran outcomes are improved (Expanded Disability Status Scale, timed up and go test, self-efficacy, and depression).
Determine which types of Caregivers will benefit most.
Determine which types of Veterans will benefit most.
Refine materials for future clinical research, translation and implementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Caregivers, Activities of Daily Living
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Intervention Type
Behavioral
Intervention Name(s)
Behavioral
Intervention Description
Education and skills building, including problem solving, cognitive restructuring, and stress management
Primary Outcome Measure Information:
Title
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Description
Caregiver primary outcome. PHQ-9, range 0-27, lower better
Time Frame
baseline, 6 months
Title
Burden Measured With the Zarit Burden Inventory
Description
Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
Time Frame
baseline, 6 months
Title
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
Description
Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better
Time Frame
baseline, 6 months
Title
Number of Patient MS Problems
Description
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
Time Frame
baseline, 6 months
Title
Bother With Patient MS Problems
Description
Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veteran being seen in MS clinic at Memphis VA
Veteran ambulatory
Caregiver/care partner who agrees to participate
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Olivia Nichols, PhD
Organizational Affiliation
Memphis VA Medical Center, Memphis, TN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memphis VA Medical Center, Memphis, TN
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Integrating Caregiver Support Into MS Care
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