CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Behavioralbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02835677
NCT02835677N/ACompleted

Integrating Caregiver Support Into MS Care

VA Office of Research and Development·interventional·Posted Jul 18, 2016·Updated Jul 24, 2019

In Brief

A clinical study evaluating Behavioral for Multiple Sclerosis. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 18, 2016
Enrollment StartSep 7, 2016
Primary CompletionApr 9, 2018
Study CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.0 years ago

Interventions

Behavioralbehavioral

Education and skills building, including problem solving, cognitive restructuring, and stress management