Integrating Caregiver Support Into MS Care

Multiple Sclerosis Clinical Trial

Official title:

Integrating Caregiver Support Into MS Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835677
• Other study ID #: E2205-P
• Secondary ID: RX002205
• Status: Completed
• Phase: N/A
• Start date: September 7, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veteran being seen in MS clinic at Memphis VA

• Veteran ambulatory

• Caregiver/care partner who agrees to participate

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Memphis VA Medical Center, Memphis, TN	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Memphis VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale	Caregiver primary outcome. PHQ-9, range 0-27, lower better	baseline, 6 months
Primary	Burden Measured With the Zarit Burden Inventory	Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better	baseline, 6 months
Primary	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
Primary	Number of Patient MS Problems	Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better	baseline, 6 months
Primary	Bother With Patient MS Problems	Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better	Baseline, 6 months