Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study
Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University
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North Carolina
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Durham、North Carolina、アメリカ、27715
- Duke University
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Determine ideal recall period for LUTS symptoms
時間枠: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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協力者と研究者
協力者
捜査官
- スタディチェア:Kevin P. Weinfurt, PhD、Duke University
- スタディチェア:Claire C. Yang, MD、University of Washington
- 主任研究者:Robert M. Merion, MD, FACS、Arbor Research Collaborative for Health - DCC
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- LURN Recall Study
- U01DK100017 (米国 NIH グラント/契約)
- U01DK100011 (米国 NIH グラント/契約)
- U01DK099932 (米国 NIH グラント/契約)
- U01DK099879 (米国 NIH グラント/契約)
- U01DK097780 (米国 NIH グラント/契約)
- U01DK097779 (米国 NIH グラント/契約)
- U01DK097776 (米国 NIH グラント/契約)
- U01DK097772 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
None- Observational Studyの臨床試験
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Radicle Science積極的、募集していない
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Digisight Technologies, Inc.わからない
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Fonds de la Recherche en Santé du QuébecUniversité de Montréal完了