Integrating Caregiver Support Into MS Care

Study Overview
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Brief Summary
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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.

Official Title
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Integrating Caregiver Support Into MS Care

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Behavioral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran being seen in MS clinic at Memphis VA Veteran ambulatory Caregiver/care partner who agrees to participate Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation | Behavioral: Behavioral<br>* Education and skills building, including problem solving, cognitive restructuring, and stress management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale | Caregiver primary outcome. PHQ-9, range 0-27, lower better | baseline, 6 months | 
| Burden Measured With the Zarit Burden Inventory | Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better | baseline, 6 months | 
| Anxiety Measured With the Generalized Anxiety Disorders 7 Scale | Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better | baseline, 6 months | 
| Number of Patient MS Problems | Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better | baseline, 6 months | 
| Bother With Patient MS Problems | Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Activities of Daily Living