Integrating Caregiver Support Into MS Care

NCT02835677 | Completed Results

• 2 other identifiers: E2205-PRX002205
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Caregivers; Activities of Daily Living

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Behavioral

Interventions

Behavioral BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Memphis VA Medical Center: collaborator

Study Sites (1)

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Linda Nichols, Co-Director Caregiver Center
• Organization: VA Medical Center

linda.nichols@va.gov

901 523-8990

Study Officials

• Linda Olivia Nichols, PhD

  Memphis VA Medical Center, Memphis, TN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 18, 2016
• Study Start: September 7, 2016
• Primary Completion: April 9, 2018
• Study Completion: June 30, 2018
• Last Updated: July 24, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)