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Validation of Bladder Health Instrument for Evaluation in Women (VIEW)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016298
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
University of California, San Diego
University of Pennsylvania
Yale University
University of Michigan
University of Illinois at Chicago
Loyola University Chicago
University of Alabama at Birmingham
Washington University School of Medicine
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans. The ability to measure bladder health and key risk and protective factors is crucial to the PLUS mission. To describe and measure the spectrum of bladder health in diverse populations, researchers need a valid and reliable instrument. To date, the Consortium's work on design of a bladder health instrument has been a culmination of expert opinion, information from focus groups, and incorporation of previously validated items and language where appropriate, along with cognitive interviews of participants from the general public. The next step in the consortium's work is to prospectively collect data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that can assess the full range of bladder health of women. This will be through a combination of general population recruitment for completing mailed surveys and clinical population recruitment for completing surveys and an in-person evaluation.

Condition or disease
Lower Urinary Tract Symptoms

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Study Type : Observational
Estimated Enrollment : 1202 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validation of Bladder Health Instrument for Evaluation in Women
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Bladder Health Instrument [ Time Frame: Will be assessed throughout the duration of study, an average of one year. ]
    Multi-item measurement is used to assess the range of bladder health dimensions as defined by the model of bladder health adopted by the PLUS consortium. It is anticipated that the self-administeredBHI instrument (PAPI or CASI) will consist of approximately 85 items: 53-67 are items all respondents will be asked to answer, and 48 are asked only of women who self-identify as experiencing a specific LUTS. The items cover the range of bladder health dimensions specified by our model.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The BHI is intended for use in the general US population and it is critical that the BHI validation include individuals who meet these criteria. The goal is to include women over the age of 18 that meet the inclusion criteria. It is our hope to get a broad spectrum of women with varying degrees of bladder health, age, race, and community.
Criteria

Inclusion Criteria:

  • Community dwelling
  • Age ≥18 years old
  • Female sex assigned at birth
  • Fluent in written and spoken English
  • Able to read and provide informed consent

Exclusion Criteria:

  • Institutional living arrangement, e.g., skilled nursing, long term care or rehabilitation center
  • Physical or mental condition that would prohibit self-administration of questionnaire either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).

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): NCT04016298


Contacts
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Contact: Melissa Constantine, PhD, MPAff 612-626-8454 cons0026@umn.edu
Contact: Abby Mengelkoch, BA 612-626-5467 mengel@umn.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35223
Contact: Clinical Trials Manager       laurieslay@uabmc.edu   
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92121
Contact: Clinical Research Coordinator       kherrala@health.ucsd.edu   
United States, Connecticut
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, Illinois
Loyola University Chicago Active, not recruiting
Chicago, Illinois, United States, 60153
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Project Manager       rutab@umich.edu   
United States, Minnesota
University of Minnesota Enrolling by invitation
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63100
Contact: Staff Scientist       plusstudy@wustl.edu   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Clinical Research Coordinator       hanna.stambakio@uphs.upenn.edu   
Sponsors and Collaborators
University of Minnesota
University of California, San Diego
University of Pennsylvania
Yale University
University of Michigan
University of Illinois at Chicago
Loyola University Chicago
University of Alabama at Birmingham
Washington University School of Medicine
Investigators
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Principal Investigator: Melissa Constantine, PhD, MPAff University of Minnesota
Principal Investigator: Emily Lukacz, MD University of California, San Diego
Publications:
Bandilla W, Bosnjak M, Altdorfer P. Survey Administration Effects?: A Comparison of Web-Based and Traditional Written Self-Administered Surveys Using the ISSP Environment Module. Soc Sci Comput Rev. 2003;21(2):235-243. doi:10.1177/0894439303021002009.
Dillman DA, Sangster RL, Tarnai J, Rockwood TH. Understanding differences in people's answers to telephone and mail surveys. New Dir Eval. 1996;1996(70):45-61. doi:10.1002/ev.1034.
Schwarz N, Strack F, Hippler H, Bishop G. The impact of administration mode on response effects in survey measurement. Jobe JB, Loftus EF, eds. Appl Cogn Psychol. 1991;5(3):193-212. doi:10.1002/acp.2350050304.
Cronbach L. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297-334. doi:10.1007/BF02310555.
Messick S. The interplay of evidence and consequences in the validation of performance assessments. ETS Res Rep Ser. 1992;1992(1):i-42. doi:10.1002/j.2333-8504.1992.tb01470.x.
Kane MT. Validating the Interpretations and Uses of Test Scores. J Educ Meas. 2013;50(1):1-73. doi:10.1111/jedm.12000.
American Educational Research Association. Standards for Educational and Psychological Testing. (Association AP, Education NC on M in, (U.S.) JC on S for E and PT, eds.). Washington, DC: Washington, DC : American Educational Research Association; 2014.
Streiner D. Health Measurement Scales : A Practical Guide to Their Development and Use. Fifth edit. (Norman GR, Cairney J, ebrary I, eds.). New York, New York: New York, New York : Oxford University Press; 2015.
Messick S. VALIDITY. Educ Test Serv Res Rep Ser. 1987;1987(2):i-208. doi:10.1002/j.2330-8516.1987.tb00244.x.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04016298    
Other Study ID Numbers: Pro00032238
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Bladder Health
LUTS
PLUS
VIEW
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations