Integrating Caregiver Support Into MS Care

VA Office of Research and Development

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Behavioral

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02835677

E2205-P

RX002205 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veteran being seen in MS clinic at Memphis VA
• Veteran ambulatory
• Caregiver/care partner who agrees to participate

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Intervention

Experimental group

Description:

Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation

Treatment:

Behavioral: Behavioral