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

This study has been completed.
Sponsor:
Collaborators:
Allergan
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
David Charles, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01879449
First received: June 12, 2013
Last updated: June 20, 2014
Last verified: May 2014
  Purpose

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
Spasticity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Spasticity in Veterans Living in a Long-term Care Facility

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Spasticity diagnosis [ Time Frame: Up to three months after consent is obtained ] [ Designated as safety issue: No ]
    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:
  • Spasticity treatment awareness and preferences survey [ Time Frame: Up to three months after consent is obtained ] [ Designated as safety issue: No ]

    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".



Enrollment: 54
Study Start Date: February 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Nursing home residents

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879449

Locations
United States, Tennessee
Tennessee State Veterans Home
Murfreesboro, Tennessee, United States, 37130
Sponsors and Collaborators
Vanderbilt University
Allergan
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: David Charles, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: David Charles, Professor and Vice-Chair, Department of Neurology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01879449     History of Changes
Other Study ID Numbers: 110470VU, VUMC38674-R, VUMC35131-R
Study First Received: June 12, 2013
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Spasticity
Veterans
Prevalence

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014