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Forbedre omsorg for kvinner med urininkontinens (EMPOWER)

14. april 2026 oppdatert av: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center

Styrke kvinner og leverandører for forbedret pleie av urininkontinens (UI) [EMPOWER-studie]

Det overordnede målet er å forbedre diagnostisering og ikke-operativ behandling av urininkontinens hos kvinner.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

I studien vil pasienter bli screenet i primærhelsetjenesten for symptomer på urininkontinens. Kvinner med positive screeningsresultater vil bli spurt om de er interessert i å delta i en implementeringsstudie der kvinner vil bli tildelt en av de tre følgende gruppene:

  1. Vanlig omsorg pluss pasientopplæringsmuligheter - Pasientens urininkontinens vil bli håndtert ved bruk av standardbehandling av pasientens primærpleie. Pasienter vil bli tilbudt opplæringsmuligheter om urininkontinens.
  2. Sykepleiernavigasjon - Sammen med behandlingen beskrevet for "Vanlig pleie pluss pasientopplæringsmuligheter", vil en sykepleiernavigator samarbeide med pasienten for å implementere atferdsendringer og gi opplæring og fysioterapialternativer. I tillegg vil navigatoren være tilgjengelig for å svare på pasientens spørsmål i tide og hjelpe pasienten med å gå gjennom behandlingsveien.
  3. Sykepleieravigasjon og ChatBot – Sammen med behandlingen beskrevet for «Vanlig omsorg pluss pasientopplæringsmuligheter» og «Sykepleiernavigasjon», vil denne gruppen inkludere en ChatBot-funksjon som lar en pasient direkte og privat kommunisere med en kunstig intelligens-drevet ChatBot, også kjent som en "samtaleagent", som vil gi utdanning og hjelpe pasienten med å navigere gjennom behandlingsveien.

Alle deltakere vil fylle ut spørreskjemaer gjennom hele påmeldingen, og data vil bli samlet inn fra medisinske journaler. Studieteamet vil analysere dataene seks måneder etter den opprinnelige avtalen/studieregistreringen, vurdere etterlevelse av terapi og hvordan terapien påvirket resultatene teamet håper å forbedre, for eksempel forbedring av symptomer. Studien vil bli implementert over tre påfølgende tidsperioder kalt Wave 1, Wave 2 og Wave 3 med primærhelsetjeneste fra to geografiske regioner som er involvert i hver bølge (totalt 6 regioner). Deltakere i Wave 1 vil bli fulgt i totalt 18 måneder, mens deltakere i Wave 2 vil bli fulgt i totalt 12 måneder, og deltakere i Wave 3 vil bli fulgt i 6 måneder. Primærpleietilbydere ved alle deltakende praksiser vil bli tilbudt utdanningsmuligheter knyttet til urininkontinens.

Studietype

Intervensjonell

Registrering (Faktiske)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals Cleveland Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. Kvinnelig pasient som besøker primærpleier ved University Hospitals (UH) Cleveland Primary Care Institute (PCI)
  2. ≥ 18 år gammel
  3. Poeng 1 eller høyere på International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

Ekskluderingskriterier:

Ingen

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm 1
Pasientutdanning
Annen: Pasientutdanning
Pasientene vil få utdanningsmuligheter.
Andre navn:
  • Utdanning
Eksperimentell: Arm 2
Pasientutdanning + sykepleiernavigasjon
Annen: Pasientutdanning
Pasientene vil få utdanningsmuligheter.
Andre navn:
  • Utdanning
Annen: Sykepleier Navigasjon
En sykepleiernavigator vil samarbeide med deltakerne for å hjelpe dem med å navigere i omsorgsveien. Navigatøren vil gi opplæring og anbefalinger for behandlingsalternativer.
Eksperimentell: Arm 3
Pasientutdanning + sykepleiernavigasjon + ChatBot
Annen: Pasientutdanning
Pasientene vil få utdanningsmuligheter.
Andre navn:
  • Utdanning
Annen: Sykepleier Navigasjon
En sykepleiernavigator vil samarbeide med deltakerne for å hjelpe dem med å navigere i omsorgsveien. Navigatøren vil gi opplæring og anbefalinger for behandlingsalternativer.
Annen: ChatBot
En ChatBot vil tillate deltakere å kommunisere direkte og privat gjennom en smarttelefon (eller annen enhet) med en kunstig intelligens-drevet ChatBot, også kjent som en "samtaleagent", som vil gi opplæring og oppmuntring til å håndtere symptomene deres.
Andre navn:
  • Atferd/trening via chatbot

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospitals Cleveland Medical Center

Etterforskere

  • Hovedetterforsker: Goutham Rao, MD, University Hospitals Cleveland Medical Center
  • Hovedetterforsker: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. september 2022

Primær fullføring (Faktiske)

23. desember 2024

Studiet fullført (Faktiske)

23. desember 2024

Datoer for studieregistrering

Først innsendt

23. august 2022

Først innsendt som oppfylte QC-kriteriene

23. august 2022

Først lagt ut (Faktiske)

25. august 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. april 2026

Sist bekreftet

1. januar 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20211420
  • 5U18HS028742-03 (U.S.A. AHRQ-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Alle individuelle deltakerdata som samles inn under forsøket vil bli gjort tilgjengelig etter avidentifikasjon.

IPD-delingstidsramme

Begynner 9 måneder og slutter 36 måneder etter publisering.

Tilgangskriterier for IPD-deling

Forskere som gir et metodisk forsvarlig forslag kan bruke dataene til ethvert formål.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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