Integrating Caregiver Support Into MS Care

CompletedNot a drug-phase studyMS (type not specified)NCT02835677

What it found

Results posted, not judged

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

GroupValueIntervalNumber analysed
Intervention5.2 units on a scale1.1 (Standard Error)25
Intervention4.6 units on a scale0.9 (Standard Error)25

Intervention

5.2

Intervention

4.6

Burden Measured With the Zarit Burden Inventory

baseline, 6 months

GroupValueIntervalNumber analysed
Intervention6.6 units on a scale1.4 (Standard Error)25
Intervention7.5 units on a scale1.3 (Standard Error)25

Intervention

6.6

Intervention

7.5

Anxiety Measured With the Generalized Anxiety Disorders 7 Scale

baseline, 6 months

GroupValueIntervalNumber analysed
Intervention5.2 units on a scale1.1 (Standard Error)25
Intervention4.6 units on a scale0.9 (Standard Error)25

Intervention

5.2

Intervention

4.6

Number of Patient MS Problems

baseline, 6 months

GroupValueIntervalNumber analysed
Intervention9.5 units on a scale0.9 (Standard Error)25
Intervention7.9 units on a scale1.1 (Standard Error)25

Intervention

9.5

Intervention

7.9

Bother With Patient MS Problems

Baseline, 6 months

GroupValueIntervalNumber analysed
Intervention6.1 units on a scale1.1 (Standard Error)25
Intervention3.9 units on a scale0.8 (Standard Error)25

Intervention

6.1

Intervention

3.9

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Intervention250 (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 sleep
  • Burden Measured With the Zarit Burden Inventory

    baseline, 6 months

  • Anxiety Measured With the Generalized Anxiety Disorders 7 Scale

    baseline, 6 months

    Mood and sleep
  • Number 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

    1. Started

      Sept 2016

    2. Main results due

      Apr 2018

    3. Finished

      Jun 2018

    4. Results posted

      Jul 2019

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