Multiple Sclerosis
Conditions
Keywords
Caregivers, Activities of Daily Living
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.
Interventions
BEHAVIORALBehavioral
Education and skills building, including problem solving, cognitive restructuring, and stress management
Sponsors
Memphis VA Medical Center
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veteran being seen in MS clinic at Memphis VA * Veteran ambulatory * Caregiver/care partner who agrees to participate
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale | baseline, 6 months | Caregiver primary outcome. PHQ-9, range 0-27, lower better |
| Burden Measured With the Zarit Burden Inventory | baseline, 6 months | Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better |
| Anxiety Measured With the Generalized Anxiety Disorders 7 Scale | baseline, 6 months | Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better |
| Number of Patient MS Problems | baseline, 6 months | Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better |
| Bother With Patient MS Problems | Baseline, 6 months | Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred in the Neurology Service at the Memphis Veterans Affairs Medical Center (VAMC).
Participants by arm
| Arm | Count |
|---|---|
| Intervention Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 13.3 |
| Anxiety change from baseline to six months Baseline | 5.2 units on a scale STANDARD_DEVIATION 5.3 |
| Anxiety change from baseline to six months Six months | 4.6 units on a scale STANDARD_DEVIATION 4.4 |
| Burden change from baseline to six months Baseline | 6.6 units on a scale STANDARD_DEVIATION 6.9 |
| Burden change from baseline to six months Six months | 7.5 units on a scale STANDARD_DEVIATION 6.2 |
| Caregiving frustrations change from baseline to six months Baseline | 0.7 units on a scale STANDARD_DEVIATION 0.7 |
| Caregiving frustrations change from baseline to six months Six months | 0.6 units on a scale STANDARD_DEVIATION 0.7 |
| Caregiving tasks change from baseline to six months Baseline | 30.7 units on a scale STANDARD_DEVIATION 19.9 |
| Caregiving tasks change from baseline to six months Six months | 31.0 units on a scale STANDARD_DEVIATION 19.2 |
| Concerning care recipient behaviors change from baseline to six months Baseline | 9.5 number of behaviors reported STANDARD_DEVIATION 4.7 |
| Concerning care recipient behaviors change from baseline to six months Six months | 8.0 number of behaviors reported STANDARD_DEVIATION 5.3 |
| Depression change from baseline to six months Baseline | 5.4 units on a scale STANDARD_DEVIATION 5.2 |
| Depression change from baseline to six months Baselinw | 7.5 units on a scale STANDARD_DEVIATION 5.5 |
| Depression change from baseline to six months Six months | 7.9 units on a scale STANDARD_DEVIATION 5.8 |
| Disability Scale change from baseline to six months Baseline Mild | 12 Participants |
| Disability Scale change from baseline to six months Baseline Moderate | 4 Participants |
| Disability Scale change from baseline to six months Baseline Severe | 8 Participants |
| Disability Scale change from baseline to six months Six monts Mild | 11 Participants |
| Disability Scale change from baseline to six months Six monts Moderate | 3 Participants |
| Disability Scale change from baseline to six months Six monts Severe | 9 Participants |
| Employment, full or part time | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hours on duty change from baseline to six months Baseline | 12.3 hours STANDARD_DEVIATION 8.9 |
| Hours on duty change from baseline to six months Six months | 12.0 hours STANDARD_DEVIATION 9.8 |
| Hours performing tasks change from baseline to six months Baseline | 3.4 hours STANDARD_DEVIATION 2.5 |
| Hours performing tasks change from baseline to six months Six months | 4.3 hours STANDARD_DEVIATION 3.7 |
| Marital status Married | 19 Participants |
| Marital status Not married | 6 Participants |
| MS Self-efficacy change from baseline to six months Baseline | 52.3 units on a scale STANDARD_DEVIATION 10.8 |
| MS Self-efficacy change from baseline to six months Six months | 54.0 units on a scale STANDARD_DEVIATION 12.6 |
| Number of behaviors that bother change from baseline to six months Baseline | 6.1 number of behaviors STANDARD_DEVIATION 5.5 |
| Number of behaviors that bother change from baseline to six months Six months | 3.9 number of behaviors STANDARD_DEVIATION 4.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 25 Participants |
| Relationship to care recipient Child | 2 Participants |
| Relationship to care recipient Parent | 3 Participants |
| Relationship to care recipient Sibling | 3 Participants |
| Relationship to care recipient Spouse | 17 Participants |
| Self Care change from baseline to six months Baseline | 9.4 units on a scale STANDARD_DEVIATION 2 |
| Self Care change from baseline to six months Six months | 10.5 units on a scale STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
| Social support change from baseline to six months Baseline | 18.0 units on a scale STANDARD_DEVIATION 6.6 |
| Social support change from baseline to six months Six months | 18.9 units on a scale STANDARD_DEVIATION 5.3 |
| Timed Up and Go Test change from baseline to six months Baseline | 4.2 seconds STANDARD_DEVIATION 1.6 |
| Timed Up and Go Test change from baseline to six months Six months | 4.1 seconds STANDARD_DEVIATION 2.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Anxiety Measured With the Generalized Anxiety Disorders 7 Scale | Baseline | 5.2 units on a scale | Standard Error 1.1 |
| Intervention | Anxiety Measured With the Generalized Anxiety Disorders 7 Scale | Six month | 4.6 units on a scale | Standard Error 0.9 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Bother With Patient MS Problems | Baseline | 6.1 units on a scale | Standard Error 1.1 |
| Intervention | Bother With Patient MS Problems | Six months | 3.9 units on a scale | Standard Error 0.8 |
Primary
Burden Measured With the Zarit Burden Inventory
Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
Time frame: baseline, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Burden Measured With the Zarit Burden Inventory | Baseline | 6.6 units on a scale | Standard Error 1.4 |
| Intervention | Burden Measured With the Zarit Burden Inventory | Six month | 7.5 units on a scale | Standard Error 1.3 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale | Six month | 4.6 units on a scale | Standard Error 0.9 |
| Intervention | Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale | Baseline | 5.2 units on a scale | Standard Error 1.1 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Patient MS Problems | Baseline | 9.5 units on a scale | Standard Error 0.9 |
| Intervention | Number of Patient MS Problems | Six month | 7.9 units on a scale | Standard Error 1.1 |