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OpenTrials
Completed

NCT Number: NCT02835677

Integrating Caregiver Support Into MS Care

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Veteran being seen in MS clinic at Memphis VA
  • Veteran ambulatory
  • Caregiver/care partner who agrees to participate

Exclusion criteria

  • None

Treatment and study plan

Behavioral

Behavioral

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

Primary outcomes

  1. Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale

    Time frame: baseline, 6 months

    Caregiver primary outcome. PHQ-9, range 0-27, lower better

  2. Burden Measured With the Zarit Burden Inventory

    Time frame: baseline, 6 months

    Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better

  3. Anxiety Measured With the Generalized Anxiety Disorders 7 Scale

    Time frame: baseline, 6 months

    Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better

  4. Number of Patient MS Problems

    Time frame: baseline, 6 months

    Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better

  5. Bother With Patient MS Problems

    Time frame: Baseline, 6 months

    Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Memphis VA Medical Center

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2016
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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