尿失禁のある女性のケアの改善 (EMPOWER)
2026年4月14日 更新者：Adonis Hijaz, MD、University Hospitals Cleveland Medical Center
尿失禁 (UI) の改善されたケアのための女性と医療従事者のエンパワーメント [EMPOWER 研究]
全体的な目標は、女性の尿失禁の診断と手術以外の管理を改善することです。
調査の概要
詳細な説明
この研究では、患者は尿失禁の症状についてプライマリケアオフィスでスクリーニングされます。 スクリーニング結果が陽性の女性は、女性が次の 3 つのグループのいずれかに割り当てられる実施研究に参加することに興味があるかどうかを尋ねられます。
- 通常のケアと患者教育の機会 - 患者の尿失禁は、患者のプライマリケア提供者による標準的なケア治療を使用して管理されます。 患者には、尿失禁に関する教育の機会が提供されます。
- ナース ナビゲーター - 「通常のケアと患者教育の機会」で説明されている治療に加えて、ナース ナビゲーターは患者と協力して行動の変化を実現し、教育と理学療法のオプションを提供します。 さらに、ナビゲーターは、患者の質問にタイムリーに回答し、患者がケア経路を進むのを助けることができます。
- 看護師のナビゲーションとチャットボット - 「通常のケアと患者教育の機会」および「看護師のナビゲーション」で説明されている治療に加えて、このグループには、患者が人工知能駆動のチャットボットと直接かつプライベートに通信できるようにするチャットボット機能が含まれます。 「会話型エージェント」とも呼ばれ、教育を提供し、患者がケア経路をナビゲートするのに役立ちます。
すべての参加者は、登録中にアンケートに回答し、データは医療記録から収集されます。 研究チームは、最初の予約/研究登録から6か月後にデータを分析し、治療への順守と、症状の改善など、チームが改善を望んでいる結果に治療がどのように影響したかを評価します. この研究は、第 1 波、第 2 波、第 3 波と呼ばれる 3 つの後続の期間にわたって実施され、各波には 2 つの地理的地域からのプライマリ ケアの実践が含まれます (合計 6 地域)。 Wave 1 の参加者は合計 18 か月、Wave 2 の参加者は合計 12 か月、Wave 3 の参加者は合計 6 か月追跡されます。 参加しているすべての診療所のプライマリケア提供者には、尿失禁に関する教育の機会が提供されます。
研究の種類
介入
入学 (実際)
400
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44106
- University Hospitals Cleveland Medical Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- ユニバーシティ ホスピタル (UH) クリーブランド プライマリー ケア インスティテュート (PCI) でプライマリー ケア提供者を訪問している女性患者
- 18歳以上
- 失禁アンケートに関する国際相談 - 尿失禁簡易フォーム（ICIQ-SF）で1以上のスコア
除外基準:
なし
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：アーム1
患者教育
|
患者には教育の機会が提供されます。
他の名前：
|
|
実験的：アーム2
患者教育 + 看護師のナビゲーション
|
患者には教育の機会が提供されます。
他の名前：
ナースナビゲーターが参加者と協力して、ケア経路をナビゲートするのを支援します。
ナビゲーターは、治療オプションに関する教育と推奨事項を提供します。
|
|
実験的：アーム3
患者教育 + 看護師ナビゲーション + チャットボット
|
患者には教育の機会が提供されます。
他の名前：
ナースナビゲーターが参加者と協力して、ケア経路をナビゲートするのを支援します。
ナビゲーターは、治療オプションに関する教育と推奨事項を提供します。
ChatBot を使用すると、参加者は、スマートフォン (またはその他のデバイス) を介して、「会話型エージェント」とも呼ばれる人工知能駆動の ChatBot と直接かつプライベートに通信でき、症状を管理するための教育と励ましを提供します。
他の名前：
|
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 |
|---|---|---|
|
Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
時間枠：Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each wave
|
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
|
|
Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
時間枠：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.
|
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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
時間枠：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.
|
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)
|
|
Change in Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
時間枠：Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
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.
|
Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
|
Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
時間枠：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)
|
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.
|
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)
|
|
Patients' Perceived Self-efficacy for UI Communication as Measured by the PEPPI
時間枠：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.
|
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)
|
|
Patient Empowerment as Measured by Number of Participants That Answered Yes to Speaking With Their Provider About UI.
時間枠：Baseline (immediately prior to start of intervention) in all Waves
|
Patient empowerment will be measured by a patient survey to measure with percentage of patients answering yes to speaking with their provider about UI.
|
Baseline (immediately prior to start of intervention) in all Waves
|
|
Change in Overactive Bladder Symptom Severity as Measured by the OABSS
時間枠：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.
|
Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
|
Overactive Bladder Symptom Severity as Measured by the OABSS
時間枠：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.
|
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)
|
|
Overactive Bladder Symptom Severity as Measured by the OABSS
時間枠：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
時間枠：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
|
|
Urinary Symptoms as Measured by the UDI-6
時間枠：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
時間枠：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)
|
|
Change in Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
時間枠：Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
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.
|
Baseline (immediately prior to start of intervention) and Months 2 and 6 post start of intervention in each Wave
|
|
Impact of UI on Patients' Quality of Life as Measured by the ICIQ-LUTSqol
時間枠：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
時間枠：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)
|
|
Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
時間枠：Months 2 and 6 post start of intervention in each Wave
|
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.
|
Months 2 and 6 post start of intervention in each Wave
|
|
Change in Patients' Perceived Symptom Improvement as Measured by Number of Participants Who Chose 1-3 on the PGI-I Scale.
時間枠：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.
時間枠：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
時間枠：1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave)
|
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.
|
1 month post completion of each Wave's enrollment period (7 months from beginning of screening period of each Wave)
|
|
Number of Practices That Implement a UI Point Person as Measured by the Practice Survey
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Goutham Rao, MD、University Hospitals Cleveland Medical Center
- 主任研究者：Adonis Hijaz, MD、University Hospitals Cleveland Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年9月6日
一次修了 (実際)
2024年12月23日
研究の完了 (実際)
2024年12月23日
試験登録日
最初に提出
2022年8月23日
QC基準を満たした最初の提出物
2022年8月23日
最初の投稿 (実際)
2022年8月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月5日
QC基準を満たした最後の更新が送信されました
2026年4月14日
最終確認日
2025年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20211420
- 5U18HS028742-03 (米国 AHRQ 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?
はい
IPD プランの説明
トライアル中に収集された個々の参加者データはすべて、匿名化後に利用可能になります。
IPD 共有時間枠
発行後 9 か月から 36 か月まで。
IPD 共有アクセス基準
方法論的に適切な提案を提供する研究者は、あらゆる目的でデータを使用できます。
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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
いいえ
米国FDA規制機器製品の研究
いいえ
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