Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study
Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University
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North Carolina
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Durham, North Carolina, 미국, 27715
- Duke University
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Determine ideal recall period for LUTS symptoms
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Kevin P. Weinfurt, PhD, Duke University
- 연구 의자: Claire C. Yang, MD, University of Washington
- 수석 연구원: Robert M. Merion, MD, FACS, Arbor Research Collaborative for Health - DCC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- LURN Recall Study
- U01DK100017 (미국 NIH 보조금/계약)
- U01DK100011 (미국 NIH 보조금/계약)
- U01DK099932 (미국 NIH 보조금/계약)
- U01DK099879 (미국 NIH 보조금/계약)
- U01DK097780 (미국 NIH 보조금/계약)
- U01DK097779 (미국 NIH 보조금/계약)
- U01DK097776 (미국 NIH 보조금/계약)
- U01DK097772 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
None- Observational Study에 대한 임상 시험
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Dorothy House HospiceUniversity Hospitals Bristol and Weston NHS Foundation Trust; University of the West of... 그리고 다른 협력자들모병
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University of AarhusCentral Denmark Region; Enversion완전한
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Guangzhou Women and Children's Medical Center아직 모집하지 않음NEC - 괴사성 장염
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University of CagliariUniversity of Milano Bicocca; University of Milan; University of Cagliari, Cagliari, Italy; Università Cattolica del Sacro Cuore, Rome, Italy모병연조직 감염 | Fournier 괴저 | 괴사성 근막염 | Fournier의 괴저이탈리아
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IRCCS San Raffaele아직 모집하지 않음
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PeriPharm완전한