Integrating Caregiver Support Into MS Care
Integrating Caregiver Support Into MS Care
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Behavioral
Results by group
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
baseline, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intervention | 5.2 units on a scale | 1.1 (Standard Error) | 25 |
| Intervention | 4.6 units on a scale | 0.9 (Standard Error) | 25 |
Intervention
Intervention
Burden Measured With the Zarit Burden Inventory
baseline, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intervention | 6.6 units on a scale | 1.4 (Standard Error) | 25 |
| Intervention | 7.5 units on a scale | 1.3 (Standard Error) | 25 |
Intervention
Intervention
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
baseline, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intervention | 5.2 units on a scale | 1.1 (Standard Error) | 25 |
| Intervention | 4.6 units on a scale | 0.9 (Standard Error) | 25 |
Intervention
Intervention
Number of Patient MS Problems
baseline, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intervention | 9.5 units on a scale | 0.9 (Standard Error) | 25 |
| Intervention | 7.9 units on a scale | 1.1 (Standard Error) | 25 |
Intervention
Intervention
Bother With Patient MS Problems
Baseline, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intervention | 6.1 units on a scale | 1.1 (Standard Error) | 25 |
| Intervention | 3.9 units on a scale | 0.8 (Standard Error) | 25 |
Intervention
Intervention
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Intervention | 25 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
baseline, 6 months
Mood and sleepBurden Measured With the Zarit Burden Inventory
baseline, 6 months
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
baseline, 6 months
Mood and sleepNumber of Patient MS Problems
baseline, 6 months
Bother With Patient MS Problems
Baseline, 6 months
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Veteran being seen in MS clinic at Memphis VA * Veteran ambulatory * Caregiver/care partner who agrees to participate
Exclusion criteria
* None
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Sept 2016
Main results due
Apr 2018
Finished
Jun 2018
Results posted
Jul 2019