Prevalence of Spasticity in Veterans Living in a Long-term Care Facility
This study has been completed.
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
David Charles, Vanderbilt University
First received: June 12, 2013
Last updated: January 25, 2016
Last verified: January 2016
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.
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Prevalence of Spasticity in Veterans Living in a Long-term Care Facility
Primary Outcome Measures:
- Spasticity diagnosis [ Time Frame: 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:
- Spasticity treatment awareness and preferences survey [ Time Frame: 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".
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Nursing home residents
- Male and female subjects of any race, aged 18 and above.
- Reside at the Tennessee State Veterans Home
- Subjects for whom it is felt that participation in the study would cause medical harm
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
|Tennessee State Veterans Home
|Murfreesboro, Tennessee, United States, 37130 |
Merz Pharmaceuticals, LLC
||David Charles, M.D.
||David Charles, Professor and Vice-Chair, Department of Neurology, Vanderbilt University
History of Changes
|Other Study ID Numbers:
VUMC38674-R ( Other Grant/Funding Number: Merz Pharma )
VUMC35131-R ( Other Grant/Funding Number: Allergan, Inc. )
|Study First Received:
||June 12, 2013
||January 25, 2016
Keywords provided by David Charles, Vanderbilt University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 21, 2017
Nervous System Diseases
Signs and Symptoms