An interventional study of Behavioral in Multiple Sclerosis, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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:
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →VA Office of Research and Development is the lead sponsor of 1,767 studies on the registry; 394 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 183 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Caregiver primary outcome. PHQ-9, range 0-27, lower better
Time frame: baseline, 6 months
Burden Measured With the Zarit Burden Inventory
Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
Time frame: 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
Time frame: baseline, 6 months
Number of Patient MS Problems
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
Time frame: baseline, 6 months
Bother With Patient MS Problems
Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
Time frame: Baseline, 6 months
Recruitment occurred in the Neurology Service at the Memphis Veterans Affairs Medical Center (VAMC).
| Milestone | Intervention |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
Caregiver primary outcome. PHQ-9, range 0-27, lower better
| units on a scale | Intervention |
|---|---|
| Baseline | 5.2 ± 1.1 |
| Six month | 4.6 ± 0.9 |
Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
| units on a scale | Intervention |
|---|---|
| Baseline | 6.6 ± 1.4 |
| Six month | 7.5 ± 1.3 |
Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better
| units on a scale | Intervention |
|---|---|
| Baseline | 5.2 ± 1.1 |
| Six month | 4.6 ± 0.9 |
Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
| units on a scale | Intervention |
|---|---|
| Baseline | 9.5 ± 0.9 |
| Six month | 7.9 ± 1.1 |
Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
| units on a scale | Intervention |
|---|---|
| Baseline | 6.1 ± 1.1 |
| Six months | 3.9 ± 0.8 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 54.8 ± 13.3 |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 55.9 ± 11.6 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 21 |
| Male | 4 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 6 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | Intervention |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 25 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 14 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Intervention |
|---|---|
| United States | 25 |
| Marital status(Participants) | Intervention |
|---|---|
| Married | 19 |
| Not married | 6 |
18 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2016 to primary completion in Apr 2018, 19 months.
Results were first posted in Jul 2019, 1 year 3 months after primary completion.
Of 868 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 19 months is below that.
Counting every sponsor, half of 889 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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