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出境医 / 临床实验 / Validation of Bladder Health Instrument for Evaluation in Women (VIEW)
Validation of Bladder Health Instrument for Evaluation in Women (VIEW)
Study Description
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 |
Study Design
| 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 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| 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).
Contacts and Locations
Contacts
| Contact: Melissa Constantine, PhD, MPAff | 612-626-8454 | cons0026@umn.edu | |
| Contact: Abby Mengelkoch, BA | 612-626-5467 | mengel@umn.edu |
Locations
| 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
| Principal Investigator: | Melissa Constantine, PhD, MPAff | University of Minnesota | |
| Principal Investigator: | Emily Lukacz, MD | University of California, San Diego |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 5, 2019 | ||||||||
| First Posted Date | July 11, 2019 | ||||||||
| Last Update Posted Date | December 4, 2020 | ||||||||
| Actual Study Start Date | July 31, 2019 | ||||||||
| Estimated Primary Completion Date | August 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Validation of Bladder Health Instrument for Evaluation in Women | ||||||||
| Official Title | Validation of Bladder Health Instrument for Evaluation in Women | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | Lower Urinary Tract Symptoms | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1202 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 31, 2021 | ||||||||
| Estimated Primary Completion Date | August 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04016298 | ||||||||
| Other Study ID Numbers | Pro00032238 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | University of Minnesota | ||||||||
| Study Sponsor | University of Minnesota | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | University of Minnesota | ||||||||
| Verification Date | December 2020 | ||||||||
