Prevalence of Spasticity in Veterans Living in a Long-term Care Facility

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT01879449
Collaborator
Allergan (Industry), Merz North America, Inc. (Industry)
54
1
14.9
3.6

Study Details

Study Description

Brief Summary

The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity at a single long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. These data will be used to strengthen a future grant application to the Department of Defense in response to their ongoing Traumatic Brain Injury initiative.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The goal of this feasibility survey is to determine the prevalence of spasticity that interferes with care or function at the Tennessee State Veterans Home (TSVH), which is a long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. In order to accomplish this goal, each of the 140 residents will be examined by the principal investigator and a medical record review will be performed; also, each patient and their medical decision-maker (if applicable), direct caregiver, and treating physician will be surveyed in order to further elucidate the barriers to treatment in this population. All consenting residents of the TSVH will be examined, but the data will be separated prior to analysis based on whether the resident is a veteran or a veteran's relative.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of Spasticity in Veterans Living in a Long-term Care Facility
    Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    May 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Spasticity diagnosis [Up to three months after consent is obtained]

      There is no biomarker for spasticity. Therefore, the diagnosis will be made on physician impression. A neurologist trained in movement disorders will examine each consented patient to determine if they have spasticity. The severity of the veteran's spasticity will be documented, including the following measures: presence of fixed contractures and presence of pain on movement.

    Secondary Outcome Measures

    1. Spasticity treatment awareness and preferences survey [Up to three months after consent is obtained]

      The investigators will use a structured interview to assess each subject's level of awareness of available treatments for spasticity. Subjects will be asked if they are aware of specific treatments for spasticity and asked to answer "yes" or "no". This interview is also designed to capture subjects' spasticity treatment preferences. Subjects will be asked if they are interested in receiving a variety of available spasticity treatments and asked to answer "yes," "no," or "maybe".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Male and female subjects of any race, aged 18 and above.

    • Reside at the Tennessee State Veterans Home

    Exclusion Criteria:
    • Subjects for whom it is felt that participation in the study would cause medical harm

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tennessee State Veterans Home Murfreesboro Tennessee United States 37130

    Sponsors and Collaborators

    • Vanderbilt University
    • Allergan
    • Merz North America, Inc.

    Investigators

    • Principal Investigator: David Charles, M.D., Vanderbilt University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Charles, Professor and Vice-Chair, Department of Neurology, Vanderbilt University
    ClinicalTrials.gov Identifier:
    NCT01879449
    Other Study ID Numbers:
    • 110470VU
    • VUMC38674-R
    • VUMC35131-R
    First Posted:
    Jun 17, 2013
    Last Update Posted:
    Jan 26, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by David Charles, Professor and Vice-Chair, Department of Neurology, Vanderbilt University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2016