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

Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879449
• Other study ID #: 110470VU
• Secondary ID: VUMC38674-RVUMC3
• Status: Completed
• Phase: N/A
• First received: June 12, 2013
• Last updated: January 25, 2016
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: January 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Locations

Country	Name	City	State
United States	Tennessee State Veterans Home	Murfreesboro	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	Allergan, Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spasticity diagnosis	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.	Up to three months after consent is obtained	No
Secondary	Spasticity treatment awareness and preferences survey	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".	Up to three months after consent is obtained	No