Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 8, 2017
First Posted Date August 16, 2017
Last Update Posted Date October 9, 2018
Actual Study Start Date January 30, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 14, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility
Official Title Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Nursing home residents
Condition
  • Spasticity, Muscle
  • Muscular Diseases
  • Musculoskeletal Disease
  • Muscle Hypertonia
  • Muscle Spasticity
  • Neuromuscular Manifestations
  • Signs and Symptoms
  • Nervous System Diseases
  • Neurologic Manifestations
Intervention 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 20, 2018)
60
Original Estimated Enrollment
 (submitted: August 14, 2017)
140
Actual Study Completion Date August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03250988
Other Study ID Numbers 170963
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party David Charles, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Allergan
Investigators
Principal Investigator: David Charles, M.D. Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date October 2018