Clinical trial NCT02835677: Integrating Caregiver Support Into MS Care
Official title: Integrating Caregiver Support Into MS Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Caregivers
Activities of Daily Living
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Memphis VA Medical Center
First posted: 2016-07-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
timeFrame: baseline, 6 months
measure: Burden Measured With the Zarit Burden Inventory
timeFrame: baseline, 6 months
measure: Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
timeFrame: baseline, 6 months
measure: Number of Patient MS Problems
timeFrame: baseline, 6 months
measure: Bother With Patient MS Problems
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Memphis VA Medical Center, Memphis, TN
state: Tennessee
Study officials:
affiliation: Memphis VA Medical Center, Memphis, TN
name: Linda Olivia Nichols, PhD
role: PRINCIPAL_INVESTIGATOR
References: