요실금 여성을 위한 관리 개선(EMPOWER)
2026년 4월 14일 업데이트: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center
요실금(UI) 관리 개선을 위한 여성 및 제공자 역량 강화 [EMPOWER 연구]
전반적인 목표는 여성의 요실금 진단 및 비수술적 관리를 개선하는 것입니다.
연구 개요
상세 설명
이 연구에서 환자는 요실금 증상에 대해 1차 진료실에서 선별 검사를 받게 됩니다. 선별 검사 결과가 긍정적인 여성은 여성이 다음 세 그룹 중 하나에 배정되는 구현 연구에 참여하는 데 관심이 있는지 질문을 받게 됩니다.
- 일반적인 치료와 환자 교육 기회 - 환자의 요실금은 환자의 1차 의료 제공자가 표준 치료를 사용하여 관리합니다. 환자에게는 요실금에 대한 교육 기회가 제공됩니다.
- 간호사 내비게이션 - "일반적인 치료와 환자 교육 기회"에 설명된 치료와 함께 간호사 내비게이터는 환자와 함께 행동 변화를 구현하고 교육 및 물리 치료 옵션을 제공합니다. 또한 네비게이터는 적시에 환자의 질문에 답하고 환자가 치료 경로를 통해 이동할 수 있도록 도와줍니다.
- 간호사 내비게이션 및 챗봇 - "일반적인 치료 및 환자 교육 기회" 및 "간호사 내비게이션"에 대해 설명된 치료와 함께 이 그룹에는 환자가 인공 지능 기반 챗봇과 직접 개인적으로 대화할 수 있는 챗봇 기능이 포함됩니다. 교육을 제공하고 환자가 치료 경로를 탐색하는 데 도움이 되는 "대화 에이전트"라고도 합니다.
모든 참가자는 등록 기간 동안 설문지를 작성하고 의료 기록에서 데이터를 수집합니다. 연구 팀은 원래 예약/연구 등록 후 6개월에 데이터를 분석하고 치료에 대한 순응도와 치료가 증상 개선과 같이 팀이 개선하고자 하는 결과에 어떤 영향을 미쳤는지 평가합니다. 이 연구는 1차, 2차, 3차라고 하는 3개의 후속 기간에 걸쳐 시행되며, 각 파동에는 두 지역의 1차 진료 사례가 포함됩니다(총 6개 지역). 1차 참가자는 총 18개월 동안, 2차 참가자는 총 12개월, 3차 참가자는 6개월 동안 추적됩니다. 참여하는 모든 진료소의 1차 진료 제공자는 요실금과 관련된 교육 기회를 제공받을 것입니다.
연구 유형
중재적
등록 (실제)
400
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 대학 병원(UH) Cleveland Primary Care Institute(PCI)에서 1차 진료 제공자를 방문하는 여성 환자
- ≥ 18세
- ICIQ-SF(International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)에서 1점 이상
제외 기준:
없음
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 팔 1
환자 교육
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환자에게는 교육의 기회가 제공됩니다.
다른 이름들:
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실험적: 팔 2
환자 교육 + 간호사 내비게이션
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환자에게는 교육의 기회가 제공됩니다.
다른 이름들:
간호사 내비게이터는 참가자와 협력하여 치료 경로를 탐색하도록 돕습니다.
내비게이터는 치료 옵션에 대한 교육 및 권장 사항을 제공합니다.
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실험적: 팔 3
환자 교육 + 간호사 내비게이션 + ChatBot
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환자에게는 교육의 기회가 제공됩니다.
다른 이름들:
간호사 내비게이터는 참가자와 협력하여 치료 경로를 탐색하도록 돕습니다.
내비게이터는 치료 옵션에 대한 교육 및 권장 사항을 제공합니다.
ChatBot을 사용하면 참가자는 "대화 에이전트"라고도 하는 인공 지능 기반 ChatBot을 사용하여 스마트폰(또는 기타 장치)을 통해 자신의 증상을 관리하기 위한 교육과 격려를 제공할 수 있습니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
기간: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave
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The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms.
The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.
|
Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave
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Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
기간: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)
|
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms.
The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.
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12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
기간: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
|
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms.
The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.
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18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
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Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
기간: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
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Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient-Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI.
The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
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Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
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Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
기간: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12)
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Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI.
The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
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12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12)
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Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
기간: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
|
Patients' perceived confidence in their ability to communicate their health concerns around UI will be assessed by the Patient- Perceived Self-Efficacy in Patient-Physician Interactions (PEPPI) Questionnaire modified for UI.
The PEPPI total score ranges from 0 to 50, with higher scores indicating greater self-efficacy.
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18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
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Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI.
기간: Baseline (immediately prior to start of intervention) in all Waves
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Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI.
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Baseline (immediately prior to start of intervention) in all Waves
|
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Change in Overactive Bladder Symptom Severity as Measured by the OABSS
기간: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS).
The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
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Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
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Overactive Bladder Symptom Severity as Measured by the OABSS
기간: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participant only last 6 months, not 12)
|
Patients' overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS).
The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
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12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participant only last 6 months, not 12)
|
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Overactive Bladder Symptom Severity as Measured by the OABSS
기간: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 and 3 participants)
|
Overactive bladder symptom severity will be assessed by the Overactive Bladder Symptom Score (OABSS).
The OABSS total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
|
18 months post start of intervention in Wave 1 (no data collected for Wave 2 and 3 participants)
|
|
Change in Urinary Symptoms as Measured by the UDI-6
기간: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6).
The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
|
Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
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Urinary Symptoms as Measured by the UDI-6
기간: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12)
|
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6).
The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
|
12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only lasted 6 months, not 12)
|
|
Urinary Symptoms as Measured by the UDI-6
기간: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
|
How bothersome a patient's urinary symptoms are will be assessed by the Urinary Distress Inventory (UDI-6).
The UDI-6 total score ranges from 0 to 100, with higher scores indicating more bothersome symptoms.
|
18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
|
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Change in Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
기간: Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
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The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
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Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
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Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
기간: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)
|
The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
|
12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)
|
|
Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
기간: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
|
The impact of urinary incontinence on quality of life will be assessed by the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol).
The ICIQ-LUTSqol total score ranges from 19 to 76, with higher scores indicating increased impact on quality of life.
|
18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
|
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Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
기간: Months 2 and 6 post start of intervention in each Wave
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Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I).
PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point.
For improvement it was calculated the number of participants who chose 1-3 only.
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Months 2 and 6 post start of intervention in each Wave
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Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
기간: 12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)
|
Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I).
PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point.
For improvement it was calculated the number of participants who chose 1-3 only.
|
12 months post start of intervention in Waves 1 and 2 (no data collected for Wave 3 participants because participation only last 6 months, not 12)
|
|
Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
기간: 18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
|
Patients' perceived improvement in UI symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I).
PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Reported outcome measure is the number of participants that scored better (1, 2, or 3) at each time point.
For improvement it was calculated the number of participants who chose 1-3 only.
|
18 months post start of intervention in Wave 1 (no data collected for Wave 2 because participants only participated for 12 months, not 18. Also no data collected for wave 3 participants because they only participated for 6 months, not 18)
|
|
Number of Practices That Maintain a UI Management Intervention as Measured by the Practice Survey
기간: 1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave)
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Maintenance of UI management intervention will be assessed by practice survey completed by participant at the practice with indication of continuation for each intervention component.
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1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave)
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Number of Practices That Implement a UI Point Person as Measured by the Practice Survey
기간: 1 month post completion of each Wave's enrollment period (7 months from beginning of screening for each Wave)
|
Implementation of a UI point person will be measured as a percentage of sites answer yes on practice survey.
|
1 month post completion of each Wave's enrollment period (7 months from beginning of screening for each Wave)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Goutham Rao, MD, University Hospitals Cleveland Medical Center
- 수석 연구원: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 9월 6일
기본 완료 (실제)
2024년 12월 23일
연구 완료 (실제)
2024년 12월 23일
연구 등록 날짜
최초 제출
2022년 8월 23일
QC 기준을 충족하는 최초 제출
2022년 8월 23일
처음 게시됨 (실제)
2022년 8월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 14일
마지막으로 확인됨
2025년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20211420
- 5U18HS028742-03 (미국 AHRQ 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
시험 기간 동안 수집된 모든 개별 참가자 데이터는 비식별 처리 후 사용할 수 있습니다.
IPD 공유 기간
출판 후 9개월부터 36개월까지.
IPD 공유 액세스 기준
방법론적으로 건전한 제안을 제공하는 연구원은 어떤 목적으로든 데이터를 사용할 수 있습니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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