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

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ClinicalTrials.gov Identifier: NCT03250988
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
David Charles, Vanderbilt University Medical Center

Study Description
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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
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
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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 : January 30, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Neurological Examination
    The subject will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of spasticity. If spasticity is found to be present during the examination, the neurologist will rate the severity of the spasticity in all affected limbs and record whether they would recommend treatment for spasticity, and if so, which treatment(s) they believe would be beneficial for the subject.

Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility [ Time Frame: 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 :
  1. Quality of life in residents of a long-term care facility [ Time Frame: 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.

  2. Physical and mental well-being in residents of a long-term care facility [ Time Frame: 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.

  3. Perceived disability in residents of a long-term care facility [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Nursing home residents
Criteria

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.

Exclusion Criteria:

  • Subjects for whom participation in the study may cause medical harm
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250988


Locations
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United States, Tennessee
Tennessee State Veterans' Homes
Murfreesboro, Tennessee, United States, 37130
Sponsors and Collaborators
Vanderbilt University Medical Center
Allergan
Investigators
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Principal Investigator: David Charles, M.D. Vanderbilt University Medical Center
More Information
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Publications:

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Responsible Party: David Charles, Professor and Vice-Chairman of Neurology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03250988    
Other Study ID Numbers: 170963
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Spasticity
Musculoskeletal Diseases
Muscular Diseases
Nervous System Diseases
Neurologic Manifestations
Muscle Hypertonia
Neuromuscular Manifestations
Urinary Incontinence
Enuresis
 Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Neuromuscular Diseases