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

Completed

• Conditions: Muscle Hypertonia; Signs and Symptoms; Nervous System Diseases; Spasticity, Muscle; Muscular Diseases; Muscle Spasticity; Neurologic Manifestations; Neuromuscular Manifestations; Musculoskeletal Disease

• Registration Number: NCT03250988
• Lead Sponsor: Vanderbilt University Medical Center

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-16
• Study Start: 2018-01-30
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-06
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

• Subjects for whom participation in the study may cause medical harm

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Tennessee State Veterans' Homes; 🇺🇸 Murfreesboro, Tennessee, United States