Integrating Caregiver Support Into MS Care

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Behavioral

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Memphis VA Medical Center, Memphis, TN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Memphis VA Medical Center
• Investigators: Principal Investigator: Linda Olivia Nichols, PhD, Memphis VA Medical Center, Memphis, TN

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2016
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Activities of Daily Living; Caregivers
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: E2205-P; RX002205 (Other Identifier: Memphis VA Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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