Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study
Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study
研究概览
详细说明
This protocol is part of an overall effort to create a state-of-the-art resource for measuring patient-reported health for patients with lower urinary tract dysfunction (LUTD). The primary purpose of this resource, known as the LURN PRO Battery, is to comprehensively characterize the self-reported experiences of patients with LUTD for the purpose of enhancing efforts to characterize and explain important subtypes of patients with LUTD (phenotypes). Secondary purposes of the LURN PRO Battery, for which additional development work will be required, include developing better patient-reported endpoints for clinical trials, monitoring symptoms in the course of clinical care, and screening patients into important subgroups for purposes of tailored interventions.
Incorporating methods the investigators have used successfully in prior measure validation work, the investigators propose to conduct a diary study in which patients record their symptoms at various time points - at the end of each day, or across multiple days. The investigators also ask them to complete self-report measures with different recall periods (i.e., 3-day, 7-day, and 30-day recall), and will determine how well each of these correspond to daily experiences recorded in more frequent assessments (i.e., end-of-day and 3-day patient bladder diaries). These data will help LURN investigators to determine the most appropriate reporting period for specific symptoms. This study can also help to identify causes of differences that exist between shorter and longer recall periods.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University
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North Carolina
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Durham、North Carolina、美国、27715
- Duke University
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Washington
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Seattle、Washington、美国、98195
- University of Washington
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- age 18 or older,
- willing and able to give informed consent,
- able to speak, read, and understand English,
- able to reliably complete self-reported questionnaires online at specified times (i.e., may exclude those who do not keep a regular schedule of sleeping during night hours), and
- experienced at least moderate severity and bother from at least 1 of the 7 targeted symptoms in the past 2 weeks and in the past 3 months
Exclusion Criteria:
- dementia or other cognitive impairment that would interfere with study participation,
- known pregnancy or delivery within past 6 months (women only)
- planned change in medications to treat LUTS in the middle of the study time frame,
- receiving active treatment for any malignancy (including maintenance medications),
- received surgery with general or spinal/epidural anesthesia in the past 3 months or planned surgery during the study time frame
- lower urinary tract instrumentation (e.g. self-catheterization or cystoscopy) in past 3 months or planned during the study time frame and
- prostate biopsy in the past 3 months or planned during the study time frame
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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No Diary Group
Group completed daily questionnaires for four weeks, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study
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None- Observational Study
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Diary Start Group
Group completed bladder diaries in week 1, daily questionnaires in week 1, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study
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None- Observational Study
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Daily Start Group
Group completed daily questionnaires in week 1, bladder diaries in week 2, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study
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None- Observational Study
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Determine ideal recall period for LUTS symptoms
大体时间：Through study completion - 30 days
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The investigators will administer and analyze the correspondence between patient's average daily recall of their LUTS utilizing seven, daily questionnaires, their weekly recall of self-reported LUTS using a 7-day recall questionnaire, as well as a questionnaire assessing their monthly LUTS recall in order to determine the best recall period to utilize when administering LUTS questionnaires in clinical settings.
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Through study completion - 30 days
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合作者和调查者
合作者
调查人员
- 学习椅：Kevin P. Weinfurt, PhD、Duke University
- 学习椅：Claire C. Yang, MD、University of Washington
- 首席研究员：Robert M. Merion, MD, FACS、Arbor Research Collaborative for Health - DCC
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- LURN Recall Study
- U01DK100017 (美国 NIH 拨款/合同)
- U01DK100011 (美国 NIH 拨款/合同)
- U01DK099932 (美国 NIH 拨款/合同)
- U01DK099879 (美国 NIH 拨款/合同)
- U01DK097780 (美国 NIH 拨款/合同)
- U01DK097779 (美国 NIH 拨款/合同)
- U01DK097776 (美国 NIH 拨款/合同)
- U01DK097772 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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None- Observational Study的临床试验
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Hospital Clinic of BarcelonaUniversitat Politècnica de Catalunya; Institut Catala de Salut; Department of Health, Generalitat... 和其他合作者未知