Forbedring af pleje til kvinder med urininkontinens (EMPOWER)
14. april 2026 opdateret af: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center
Styrkelse af kvinder og udbydere til forbedret pleje af urininkontinens (UI) [EMPOWER-undersøgelse]
Det overordnede mål er at forbedre diagnosticering og ikke-operativ behandling af urininkontinens hos kvinder.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
I undersøgelsen vil patienter blive screenet på primære kontorer for symptomer på urininkontinens. Kvinder med positive screeningsresultater vil blive spurgt, om de er interesserede i at deltage i en implementeringsundersøgelse, hvor kvinder vil blive tildelt en af de tre følgende grupper:
- Sædvanlig pleje plus uddannelsesmuligheder for patienten - Patientens urininkontinens vil blive styret ved hjælp af standardbehandling af patientens primære behandler. Patienterne vil blive tilbudt undervisningsmuligheder om urininkontinens.
- Sygeplejerskenavigation - Sammen med behandlingen beskrevet for "Sædvanlig pleje plus patientuddannelsesmuligheder" vil en sygeplejerskenavigator arbejde sammen med patienten om at implementere adfærdsændringer og give uddannelses- og fysioterapimuligheder. Derudover vil navigatoren være tilgængelig til at besvare patientens spørgsmål rettidigt og hjælpe patienten med at bevæge sig gennem plejeforløbet.
- Sygeplejerskenavigation og ChatBot - Sammen med behandlingen beskrevet for "Sædvanlig pleje plus patientuddannelsesmuligheder" og "Sygeplejerskenavigation" vil denne gruppe inkludere en ChatBot-funktion, som vil give en patient mulighed for direkte og privat at kommunikere med en kunstig intelligens-drevet ChatBot, også kendt som en "samtaleagent", der vil give uddannelse og hjælpe patienten med at navigere i plejeforløbet.
Alle deltagere vil udfylde spørgeskemaer under hele deres tilmelding, og data vil blive indsamlet fra lægejournaler. Undersøgelsesteamet vil analysere dataene seks måneder efter den oprindelige aftale/tilmelding til studiet, vurdere overholdelse af terapi og hvordan terapien påvirkede de resultater, holdet håber at forbedre, såsom forbedring af symptomer. Undersøgelsen vil blive implementeret over tre efterfølgende tidsperioder kaldet Wave 1, Wave 2 og Wave 3 med primærpleje fra to geografiske regioner involveret i hver bølge (6 regioner i alt). Deltagerne i Wave 1 følges i alt i 18 måneder, mens deltagere i Wave 2 i alt følges i 12 måneder, og deltagere i Wave 3 følges i 6 måneder. Primærplejeudbydere på alle deltagende praksisser vil blive tilbudt uddannelsesmuligheder relateret til urininkontinens.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
400
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Kvindelig patient, der besøger primærplejer på University Hospitals (UH) Cleveland Primary Care Institute (PCI)
- ≥ 18 år gammel
- Score 1 eller højere på International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
Ekskluderingskriterier:
Ingen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1
Patientuddannelse
|
Patienterne vil få uddannelsesmuligheder.
Andre navne:
|
|
Eksperimentel: Arm 2
Patientuddannelse + Sygeplejerske Navigation
|
Patienterne vil få uddannelsesmuligheder.
Andre navne:
En sygeplejerskenavigator vil arbejde sammen med deltagerne for at hjælpe dem med at navigere i plejeforløbet.
Navigatoren vil give undervisning og anbefalinger til behandlingsmuligheder.
|
|
Eksperimentel: Arm 3
Patientuddannelse + Sygeplejerske Navigation + ChatBot
|
Patienterne vil få uddannelsesmuligheder.
Andre navne:
En sygeplejerskenavigator vil arbejde sammen med deltagerne for at hjælpe dem med at navigere i plejeforløbet.
Navigatoren vil give undervisning og anbefalinger til behandlingsmuligheder.
En ChatBot vil give deltagere mulighed for at kommunikere direkte og privat via en smartphone (eller anden enhed) med en kunstig intelligens-drevet ChatBot, også kendt som en "samtaleagent", der vil give uddannelse og opmuntring til at håndtere deres symptomer.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Tidsramme: 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)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patients' UI Symptoms as Measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Goutham Rao, MD, University Hospitals Cleveland Medical Center
- Ledende efterforsker: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. september 2022
Primær færdiggørelse (Faktiske)
23. december 2024
Studieafslutning (Faktiske)
23. december 2024
Datoer for studieregistrering
Først indsendt
23. august 2022
Først indsendt, der opfyldte QC-kriterier
23. august 2022
Først opslået (Faktiske)
25. august 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. april 2026
Sidst verificeret
1. januar 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Vandladningsforstyrrelser
- Nedre urinvejssymptomer
- Urologiske manifestationer
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Ufrivillig vandladning
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Forebyggende sundhedsydelser
- Socioøkonomiske faktorer
- Befolkningsegenskaber
- Sundhedsuddannelse
- Uddannelsesstatus
- Patientuddannelse som emne
Andre undersøgelses-id-numre
- 20211420
- 5U18HS028742-03 (U.S.A. AHRQ bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Alle de individuelle deltagerdata indsamlet under forsøget vil blive gjort tilgængelige efter afidentifikation.
IPD-delingstidsramme
Begyndende 9 måneder og slutter 36 måneder efter offentliggørelse.
IPD-delingsadgangskriterier
Forskere, der giver et metodisk forsvarligt forslag, kan bruge dataene til ethvert formål.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .