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| ID | Type | Description | Link |
|---|---|---|---|
| RX002205 | Other Identifier | Memphis VA Medical Center |
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| Name | Class |
|---|---|
| Memphis VA Medical Center | FED |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral | Behavioral | Education and skills building, including problem solving, cognitive restructuring, and stress management |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Olivia Nichols, PhD | Memphis VA Medical Center, Memphis, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memphis VA Medical Center, Memphis, TN | Memphis | Tennessee | 38104 | United States |
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Recruitment occurred in the Neurology Service at the Memphis Veterans Affairs Medical Center (VAMC).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Caregiver |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale | Caregiver primary outcome. PHQ-9, range 0-27, lower better | Posted | Mean | Standard Error | units on a scale | baseline, 6 months |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Nichols, Co-Director Caregiver Center | VA Medical Center | 901 523-8990 | 5082 | linda.nichols@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2016 | Feb 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Standard Deviation |
| years |
|
| Age, Continuous | Care Recipient | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Caregiver | Count of Participants | Participants |
|
| Sex: Female, Male | Care Recipient | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Caregiver | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Marital status | Caregiver | Count of Participants | Participants |
|
| Relationship to care recipient | Count of Participants | Participants |
|
| Anxiety change from baseline to six months | Caregiver, General Anxiety Disorders Scale-7, (GAD-7), range 0-21, lower better | Lost to followup | Mean | Standard Deviation | units on a scale |
|
| Depression change from baseline to six months | Caregiver, Patient Health Questionnaire - 9, PHQ-9, range 0-27, lower better | Lost to followup | Mean | Standard Deviation | units on a scale |
|
| Burden change from baseline to six months | Caregiver, Zarit Burden Inventory, 12 item, 0-48, lower better | Lost to followup | Mean | Standard Deviation | units on a scale |
|
| Caregiving tasks change from baseline to six months | Caregiving Tasks in Multiple Sclerosis Scale (CTiMSS), range 0-96, lower better | Lost to followup | Mean | Standard Deviation | units on a scale |
|
| Social support change from baseline to six months | Caregiver, received support, satisfaction, negative interactions, range 0-30, higher better | Lost to followup | Mean | Standard Deviation | units on a scale |
|
| Self Care change from baseline to six months | Caregiver, health services use, range 0-14, higher is better | Lost to followup | Mean | Standard Deviation | units on a scale |
|
| Caregiving frustrations change from baseline to six months | Feel like yelling or hitting, range 0-4, lower better | Lost to followup | Mean | Standard Deviation | units on a scale |
|
| Hours on duty change from baseline to six months | Mahoney Vigilance Scale, number of hours caregiver feels on duty, range 0-24 | Lost to followup | Mean | Standard Deviation | hours |
|
| Hours performing tasks change from baseline to six months | Mahoney Vigilance Scale, number of hours actually performing tasks, range 0-24 | Missing data, Lost to followup | Mean | Standard Deviation | hours |
|
| Concerning care recipient behaviors change from baseline to six months | Number of possible patient troubling behaviors or concerns, range, 0-27 | Lost to followup | Mean | Standard Deviation | number of behaviors reported |
|
| Number of behaviors that bother change from baseline to six months | Number of possible patient troubling behaviors or concerns that bother the caregiver, range 0-27 | Lost to followup | Mean | Standard Deviation | number of behaviors |
|
| Timed Up and Go Test change from baseline to six months | Care Recipient, Timed Up and Go Test (TUGT), seconds (for analysis - square root transformed seconds), fewer better | Missing data | Mean | Standard Deviation | seconds |
|
| MS Self-efficacy change from baseline to six months | Care Recipient, Multiple Sclerosis Self-Efficacy Scale (MSSS), score 14-84, higher better | Missing data | Mean | Standard Deviation | units on a scale |
|
| Disability Scale change from baseline to six months | Care Recipient, Expanded Disability Status Scale (EDSS),0-10, lower better. Categories are percentage with mild (0-2.5 points), moderate (3.0-5.0), and severe (> 6) disability. | Missing data | Count of Participants | Participants |
|
| Depression change from baseline to six months | Care Recipient, Patient Health Questionnaire - 9, PHQ-9, range 0-27, lower better | Missing data | Mean | Standard Deviation | units on a scale |
|
| Employment, full or part time | Caregiver | Count of Participants | Participants | No |
|
| Employment, full or part time | Care Recipient | Count of Participants | Participants |
|
|
| Primary | Burden Measured With the Zarit Burden Inventory | Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better | Posted | Mean | Standard Error | units on a scale | 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 | Posted | Mean | Standard Error | units on a scale | baseline, 6 months |
|
|
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| Primary | Number of Patient MS Problems | Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better | Posted | Mean | Standard Error | units on a scale | 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 | Posted | Mean | Standard Error | units on a scale | Baseline, 6 months |
|
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|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |