- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05515198
Verbesserung der Versorgung von Frauen mit Harninkontinenz (EMPOWER)
Stärkung von Frauen und Anbietern für eine verbesserte Versorgung von Harninkontinenz (UI) [EMPOWER-Studie]
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
In der Studie werden Patienten in Praxen der Grundversorgung auf Symptome von Harninkontinenz untersucht. Frauen mit positiven Screening-Ergebnissen werden gefragt, ob sie an einer Teilnahme an einer Implementierungsstudie interessiert sind, in der die Frauen einer der drei folgenden Gruppen zugeordnet werden:
- Übliche Pflege plus Möglichkeiten zur Patientenaufklärung – Die Harninkontinenz des Patienten wird unter Anwendung der Standardbehandlung durch den Hausarzt des Patienten behandelt. Den Patienten werden Aufklärungsmöglichkeiten über Harninkontinenz angeboten.
- Krankenschwesternavigation – Zusammen mit der Behandlung, die für „Übliche Pflege plus Patientenaufklärungsmöglichkeiten“ beschrieben wird, arbeitet eine Krankenschwesternavigation mit dem Patienten zusammen, um Verhaltensänderungen umzusetzen und Schulungs- und Physiotherapieoptionen anzubieten. Darüber hinaus steht der Navigator zur Verfügung, um die Fragen des Patienten rechtzeitig zu beantworten und dem Patienten zu helfen, sich durch den Behandlungspfad zu bewegen.
- Nurse Navigation and ChatBot – Zusammen mit der Behandlung, die für „Übliche Pflege plus Möglichkeiten zur Patientenaufklärung“ und „Nurse Navigation“ beschrieben wurde, wird diese Gruppe eine ChatBot-Funktion enthalten, die es einem Patienten ermöglicht, direkt und privat mit einem von künstlicher Intelligenz gesteuerten ChatBot zu kommunizieren. auch als "Gesprächsagent" bekannt, der Aufklärung bietet und dem Patienten hilft, sich auf dem Behandlungspfad zurechtzufinden.
Alle Teilnehmer werden während ihrer Einschreibung Fragebögen ausfüllen und Daten werden aus Krankenakten gesammelt. Das Studienteam wird die Daten sechs Monate nach dem ursprünglichen Termin/Studieneintritt analysieren, die Einhaltung der Therapie und die Auswirkungen der Therapie auf die Ergebnisse, die das Team zu verbessern hofft, wie z. B. die Verbesserung der Symptome, bewerten. Die Studie wird über drei aufeinanderfolgende Zeiträume durchgeführt, die als Welle 1, Welle 2 und Welle 3 bezeichnet werden, wobei an jeder Welle Hausarztpraxen aus zwei geografischen Regionen beteiligt sind (insgesamt 6 Regionen). Teilnehmer an Welle 1 werden insgesamt 18 Monate lang beobachtet, während Teilnehmer an Welle 2 insgesamt 12 Monate lang verfolgt werden und Teilnehmer an Welle 3 sechs Monate lang beobachtet werden. Den Hausärzten aller teilnehmenden Praxen werden Aufklärungsmöglichkeiten zum Thema Harninkontinenz angeboten.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44106
- University Hospitals Cleveland Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- Patientin beim Besuch eines Hausarztes am Cleveland Primary Care Institute (PCI) der Universitätskliniken (UH)
- ≥ 18 Jahre alt
- Punktzahl 1 oder höher im International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Ausschlusskriterien:
Keiner
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Arm 1
Patientenaufklärung
|
Den Patienten werden Bildungsmöglichkeiten geboten.
Andere Namen:
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Experimental: Arm 2
Patientenaufklärung + Pflegenavigation
|
Den Patienten werden Bildungsmöglichkeiten geboten.
Andere Namen:
Ein Krankenschwesternavigator wird mit den Teilnehmern zusammenarbeiten, um ihnen zu helfen, den Pflegepfad zu navigieren.
Der Navigator bietet Schulungen und Empfehlungen für Behandlungsoptionen.
|
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Experimental: Arm 3
Patientenaufklärung + Pflegenavigation + ChatBot
|
Den Patienten werden Bildungsmöglichkeiten geboten.
Andere Namen:
Ein Krankenschwesternavigator wird mit den Teilnehmern zusammenarbeiten, um ihnen zu helfen, den Pflegepfad zu navigieren.
Der Navigator bietet Schulungen und Empfehlungen für Behandlungsoptionen.
Ein ChatBot wird es den Teilnehmern ermöglichen, direkt und privat über ein Smartphone (oder ein anderes Gerät) mit einem von künstlicher Intelligenz gesteuerten ChatBot zu kommunizieren, der auch als „Gesprächsagent“ bekannt ist, der Aufklärung und Ermutigung bietet, ihre Symptome zu bewältigen.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Zeitfenster: 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
|
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Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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)
|
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Number of Practices That Implement a UI Point Person as Measured by the Practice Survey
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Goutham Rao, MD, University Hospitals Cleveland Medical Center
- Hauptermittler: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Männliche Urogenitalerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Störungen beim Wasserlassen
- Symptome der unteren Harnwege
- Urologische Manifestationen
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Harninkontinenz
- Gesundheitsdienste
- Belegschaft und Dienstleistungen für Gesundheitseinrichtungen
- Präventive Gesundheitsdienste
- Sozioökonomische Faktoren
- Bevölkerungseigenschaften
- Gesundheitserziehung
- Bildungsstatus
- Patientenerziehung als Thema
Andere Studien-ID-Nummern
- 20211420
- 5U18HS028742-03 (US-AHRQ-Zuschuss/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
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