Integrating Caregiver Support Into MS Care

NCT ID: NCT02835677

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-07
• Study Completion Date: 2018-06-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Behavioral

Intervention Type: BEHAVIORAL

Education and skills building, including problem solving, cognitive restructuring, and stress management

Interventions

Behavioral

Education and skills building, including problem solving, cognitive restructuring, and stress management

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memphis VA Medical Center

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Olivia Nichols, PhD

Role: PRINCIPAL_INVESTIGATOR

Memphis VA Medical Center, Memphis, TN

Locations

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RX002205

Identifier Type: OTHER

Identifier Source: secondary_id

E2205-P

Identifier Type: -

Identifier Source: org_study_id