Hjælper fattige rygere med at holde op
4. december 2023 opdateret af: Matthew Kreuter, Washington University School of Medicine
Hjælp de fattige med at holde op med at ryge: Specialiserede pauselinjer og opfylde grundlæggende behov
Ved at bruge et 2x2 randomiseret faktorielt design vil vi udføre et landsdækkende feltforsøg i Missouri for at sammenligne de relative og kombinerede effekter af disse to strategier til at forstærke et eksisterende, evidensbaseret tobaks-quitline-program.
Blandt 2000 lavindkomstrygere vil halvdelen modtage standard Missouri quitline-tjenester og halvdelen vil modtage nye Specialized Quitline-tjenester målrettet denne gruppe.
I hver af disse grupper vil halvdelen også modtage opkald fra en uddannet navigatør for at hjælpe dem med at håndtere udækkede grundlæggende behov og den medfølgende psykiske lidelse, der fungerer som barrierer for rygestop.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
2-1-1 informationsspecialister vil levere standardservice og derefter spørge et tilfældigt antal opkald om dagen, om de vil være villige til at besvare et par sundhedsspørgsmål som en del af en ny 2-1-1 service. Opkaldsberettigede til at modtage invitationen til at screene for studieberettigelse vil være: Missouri-beboere, der ringer for sig selv, engelsktalende og ikke i akut krise. Berettigede rygere vil derefter blive spurgt, om de er villige til at dele deres kontaktoplysninger med et forskerhold, der udfører en undersøgelse for at hjælpe rygere med at holde op. Rygere, der accepterer at dele deres kontaktoplysninger, vil blive betragtet som "tilmeldte". Uddannede 2-1-1 operatører vil registrere alle rekrutteringsscreeningsdata i en sikker elektronisk database, der deles med forskningspersonale. Forskningspersonale vil forsøge at nå tilmeldte rygere via telefon senest den næste hverdag.
Alere vil gennem Missouri Tobacco Quitline levere quitline-tjenester til rygere under alle studieforhold. Kontaktoplysninger og studiegruppeopgave for rygere vil blive givet til Alere via sikker dataoverførsel.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1944
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63130
- Washington University in St. Louis
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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
Ja
Beskrivelse
Inklusionskriterier:
- 18 år og ældre
- bosiddende i Missouri
- engelsktalende
- Ikke i krise
- Ryge cigaretter hver dag i ugen
- Planlægger at holde op med at ryge inden for de næste 30 dage
- Komfortabelt at modtage opkald fra rygeekspert og projektteam
- Er villig til at oplyse telefonnumre, der skal kontaktes
Ekskluderingskriterier:
- Gravid eller planlægger at blive gravid inden for de næste 3 måneder
- Ammer i øjeblikket
- Forsikring gennem arbejdsgiver
- Er i øjeblikket tilmeldt rygestoplinjen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Standard Quitline
Deltagerne vil modtage standard Missouri quitline-tjenester
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Eksperimentel: Specialiseret Quitline
Deltagerne vil modtage en forbedret version af standard quitline-tjenesterne
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Rygere med meget lav indkomst adskiller sig fra andre rygere på vigtige måder, der ikke altid behandles af standard quitline-tjenester.
Forskerholdet og Alere-medarbejderne har skabt brugerdefinerede protokoller, scripts, prompter og andet indhold for at maksimere interventionsrelevans og acceptabilitet for rygere med meget lav indkomst.
Research Implementation Unit (RIU) coaches, der skal levere de specialiserede Quitline-tjenester, har modtaget træning fra klinisk quitline-personale, forskerteamet og 2-1-1 personale, som har stor erfaring med målgruppen.
Fokusområder for træning og karakteristisk indhold og protokol for Specialized Quitline inkluderer: sundhedskompetence, abstrakt vs. konkret sprog, levet erfaring, ressourcebegrænsninger, fremtidsorientering, at få cigaretter, levesituation, telefon/internetadgang.
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Eksperimentel: Standard Quitline med Basic Needs Navigator
Deltagerne modtager standard quitline-tjenester med navigator
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Navigatorer vil: (1) identificere og vurdere rygeres behov, herunder årsagerne til, at de kaldte 2-1-1; (2) i fællesskab skabe løsninger for at imødekomme behovene; (3) udvikle planer for at udføre løsningerne, herunder; (4) hjælpe med at prioritere blandt flere behov; (5) identificere samfundsressourcer, der kan hjælpe med at løse problemet; (6) bestemme berettigelse til tjenester; (7) hjælpe rygere med at få adgang til tilgængelige ressourcer ved at planlægge aftaler og give påmindelser om aftaler; (8) forberede rygere til at interagere med servicebureauer og/eller fungere som advokat på deres vegne; (9) yde instrumentel støtte, såsom at arrangere transport; (10) aktivt gribe ind for at løse barrierer for basale behovsløsninger; (11) føre tilsyn med opfølgning af problemløsningshandlinger; og (12) gennemgå de fremskridt, der er gjort med at løse uopfyldte basale behov og tilpasse løsninger i overensstemmelse hermed.
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Eksperimentel: Specialiseret Quitline med Basic Needs Navigator
Deltagerne modtager forbedrede quitline-tjenester med navigator
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Rygere med meget lav indkomst adskiller sig fra andre rygere på vigtige måder, der ikke altid behandles af standard quitline-tjenester.
Forskerholdet og Alere-medarbejderne har skabt brugerdefinerede protokoller, scripts, prompter og andet indhold for at maksimere interventionsrelevans og acceptabilitet for rygere med meget lav indkomst.
Research Implementation Unit (RIU) coaches, der skal levere de specialiserede Quitline-tjenester, har modtaget træning fra klinisk quitline-personale, forskerteamet og 2-1-1 personale, som har stor erfaring med målgruppen.
Fokusområder for træning og karakteristisk indhold og protokol for Specialized Quitline inkluderer: sundhedskompetence, abstrakt vs. konkret sprog, levet erfaring, ressourcebegrænsninger, fremtidsorientering, at få cigaretter, levesituation, telefon/internetadgang.
Navigatorer vil: (1) identificere og vurdere rygeres behov, herunder årsagerne til, at de kaldte 2-1-1; (2) i fællesskab skabe løsninger for at imødekomme behovene; (3) udvikle planer for at udføre løsningerne, herunder; (4) hjælpe med at prioritere blandt flere behov; (5) identificere samfundsressourcer, der kan hjælpe med at løse problemet; (6) bestemme berettigelse til tjenester; (7) hjælpe rygere med at få adgang til tilgængelige ressourcer ved at planlægge aftaler og give påmindelser om aftaler; (8) forberede rygere til at interagere med servicebureauer og/eller fungere som advokat på deres vegne; (9) yde instrumentel støtte, såsom at arrangere transport; (10) aktivt gribe ind for at løse barrierer for basale behovsløsninger; (11) føre tilsyn med opfølgning af problemløsningshandlinger; og (12) gennemgå de fremskridt, der er gjort med at løse uopfyldte basale behov og tilpasse løsninger i overensstemmelse hermed.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Afholdenhed 6 måneder
Tidsramme: 6 måneder efter baseline
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Rapportér 7-dages punktprævalens afholdenhed målt 6 måneder efter -baseline
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6 måneder efter baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Afholdenhed 3 måneder
Tidsramme: 3 måneder efter baseline
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Rapporter 7-dages punktprævalens abstinens målt 3 måneder efter baseline
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3 måneder efter baseline
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24 timers afslutningsforsøg
Tidsramme: 6 måneder efter baseline
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Rapportér rygestop i mindst 24 timer under intervention
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6 måneder efter baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Matthew Kreuter, PhD, Washington University School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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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)
5. juni 2017
Primær færdiggørelse (Faktiske)
1. juli 2022
Studieafslutning (Faktiske)
1. juli 2022
Datoer for studieregistrering
Først indsendt
19. juni 2017
Først indsendt, der opfyldte QC-kriterier
20. juni 2017
Først opslået (Faktiske)
21. juni 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. december 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. december 2023
Sidst verificeret
1. december 2023
Mere information
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Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01CA201429 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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 .