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

October 6, 2018 updated by: David Charles, Vanderbilt University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Tennessee State Veterans' Homes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nursing home residents

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to three months after consent is obtained

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to three months after consent is obtained
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.
Up to three months after consent is obtained
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.
Up to three months after consent is obtained

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2018

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (ACTUAL)

August 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 6, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170963

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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