Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03250988

Collaborator

Allergan (Industry)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to improve spasticity diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral.

Condition or Disease	Intervention/Treatment	Phase
Spasticity, Muscle Muscular Diseases Musculoskeletal Disease Muscle Hypertonia Muscle Spasticity Neuromuscular Manifestations Signs and Symptoms Nervous System Diseases Neurologic Manifestations	Diagnostic Test: Neurological Examination

Detailed Description

The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral. This will be done by assessing the relatedness of comorbid conditions in patients with spasticity. Emphasis will be placed on urinary incontinence, as previous work has suggested a link between the two conditions. An additional aim of this study is to assess health-related quality of life measures in this population. A medical record review will be performed for all consenting participants residing in Tennessee State Veterans' Homes, which is a long-term care facility in Murfreesboro, TN. Participants will also be asked to complete a brief questionnaire assessing their perceived health-related quality of life, physical wellbeing, and mental wellbeing.

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility

Actual Study Start Date :

Jan 30, 2018

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Outcome Measures

Primary Outcome Measures

Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility [Up to three months after consent is obtained]
Prevalence of spasticity will be determined by recording the presence/absence of spasticity based on the neurological examination performed on all consenting residents of the long-term care facility. Prevalence of urinary incontinence will be determined by medical record review of all consenting residents of the long-term care facility. The research coordinator will report prevalence of comorbid spasticity and incontinence as a descriptive statistic.

Secondary Outcome Measures

Quality of life in residents of a long-term care facility [Up to three months after consent is obtained]
Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their perceived health-related quality of life. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their health-related quality of life.
Physical and mental well-being in residents of a long-term care facility [Up to three months after consent is obtained]
Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their physical and mental well-being. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their physical and mental well-being.
Perceived disability in residents of a long-term care facility [Up to three months after consent is obtained]
Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their perceived disability. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their disability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female subjects of any race, aged 18 and above
Resident of the selected long-term care facility
The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.