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

Completed

• Conditions: Spasticity

• Registration Number: NCT01879449
• Lead Sponsor: Vanderbilt University

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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-17
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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".

Trial Locations

Locations (1)

Tennessee State Veterans Home; 🇺🇸 Murfreesboro, Tennessee, United States