Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT02835677
Study type Interventional
Source VA Office of Research and Development
Status Completed
Phase N/A
Start date September 7, 2016
Completion date June 30, 2018

See also
  Status Clinical Trial Phase
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Recruiting NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Active, not recruiting NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4
Completed NCT02232061 - Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks Phase 4
Recruiting NCT03983681 - Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS N/A
Enrolling by invitation NCT04676204 - Relationship Between Oral DMT Burden and Adherence in MS
Recruiting NCT03424733 - Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects Phase 4
Active, not recruiting NCT03122652 - Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome Phase 3
Completed NCT03326505 - Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment Phase 1/Phase 2
Active, not recruiting NCT03396822 - Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis
Completed NCT04035889 - Melatonin for Sleep in MS N/A
Recruiting NCT03854123 - Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics
Active, not recruiting NCT03355365 - Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis Phase 2