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Mobilstopstøtte til Latino-rygere

10. april 2024 opdateret af: Paula Cupertino, University of Rochester

Beslutningstekst: Mobilstopstøtte til Latino-rygere

Det primære formål med denne undersøgelse er at undersøge effektiviteten af ​​Decídetexto, en innovativ mobil rygestop-intervention, der inkorporerer to elementer: 1) en tablet-baseret e-sundhedsplatform, der indsamler personlig rygerelateret information for at understøtte udviklingen af ​​et individuelt rygestop planlægge og guide det efterfølgende SMS-program; og 2) et 12-ugers SMS-"færdighedsbaseret rådgivning"-program (dvs. adfærdsstøtte), der inkluderer uddannelsesinformation, adfærdsstrategier, motiverende beskeder og farmakoterapi-støtte drevet af information indhentet fra både tabletprogrammet og brugerens tekstbeskeder . Efterforskerne vil evaluere dets effektivitet i forhold til en standardbehandlingstilstand, der giver højkvalitets trykte rygestopmaterialer sammen med henvisning til telefonstoprådgivning. Deltagerne i begge grupper får adgang til gratis farmakoterapi via et gratis undersøgelsesnummer. Erfarne Promotores de Salud (Community Health Workers) vil bruge samfunds- og klinikbaseret opsøgende arbejde til at rekruttere latino-rygere til undersøgelsen. Deltagere i begge tilstande vil gennemføre opfølgende vurdering ved afslutningen af ​​behandlingen (uge 12) og måned 6 (primært resultat). Vores hypotese er, at rygere i Decídetexto i 6. måned vil have signifikant højere cotinin-verificeret 7-dages-punktsprævalensabstinens (ingen cigaretter i de sidste 7 dage) end rygere i kontrolarmen.

Studieoversigt

Detaljeret beskrivelse

Latinoamerikanere er mindre tilbøjelige end ikke-spansktalende hvide til at have adgang til sundhedspleje, at have viden om eksisterende rygestopressourcer, at modtage råd om at stoppe med at ryge og at bruge farmakoterapi til at stoppe med at ryge. På trods af disse markante tobaksrelaterede forskelle er der mangel på effektive interventioner designet til Latino-samfundet. Mobilteknologi giver en lovende metode til at overvinde barrierer og give en kulturelt kongruent behandling til latino-rygere. Implementering af mobile interventioner blandt latinoer forbliver minimal på trods af, at latinoer er de hurtigste brugere af mobilteknologi, der bruger smartphones og tekstbeskeder i højere grad end ikke-spansktalende hvide gør. En effektiv, kulturelt passende intervention ved hjælp af mobile teknologiske metoder med potentiale for udbredt anvendelse af klinikker og lokalsamfundsbaserede tjenesteudbydere kan dramatisk øge rækkevidden og indvirkningen på Latino-sundheden.

Decídetext er en kulturelt kongruent metode til at øge adgangen til stoptjenester for latinorygere og hjælpe dem med at udvikle, implementere og følge en personlig stopplan. Hvis det lykkes, kan denne intervention let implementeres i forskellige miljøer, herunder samfundsmiljøer, klinikker, apoteker, skadestuer og klinikkens venteområder og reducere behandlingsforskelle, reducere tobaksrelateret sygelighed og dødelighed og forbedre sundheden og livskvaliteten i ca. 9 millioner latino-rygere i USA.

Mål 1. At evaluere virkningen af ​​det kulturelt tilpassede Decídetext-program versus standardbehandling på rygeafholdenhed ved 6. måned blandt latino-rygere. Ved 6. måned vil rygere i Decídetext have signifikant højere cotinin-verificeret 7-dages-punktsprævalensabstinens (ingen cigaretter i de sidste 7 dage) end rygere i kontrolarmen. Programmets effektivitet vil også blive undersøgt i uge 12 (afslutningen af ​​behandlingen) for at vurdere forandringsmekanismer og i måned 12 for at give udvidede resultatdata.

Mål 2. At vurdere terapeutisk alliance, anvendelse af farmakoterapi og selveffektivitet som mediatorer af den formodede behandlingseffekt på cotinin-verificeret 7-dages rygeafholdenhed ved 6. måned blandt latino-rygere. Vores hypotese er, at Decídetext vil have større effekt til rygestop end standardbehandling ved at øge terapeutisk alliance, udnyttelse af farmakoterapi og selveffektivitet til at holde op.

Mål 3. At gennemføre en procesevaluering, der kan informere om resultater og fremtidige forbedringer. Evalueringen af ​​Decídetext omfatter: 1) tilfredshed med programmet og dets komponenter; 2) brugsmønstre for SMS-system og almindelige indholdstemaer i SMS-interaktioner mellem deltagere.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

457

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Medical Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack Meridian Health - Hackensack University Medical Center
    • New York
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester 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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Er du latinamerikansk eller latino?
  • Ved du, hvordan man læser og taler engelsk og/eller spansk?
  • Er du mindst 21 år gammel?
  • Har du røget cigaretter i mindst 6 måneder?
  • Inden for en typisk uge, hvor mange dage ryger du (selv et sug)?
  • Hvor mange dage bruger andre tobaksvarer inden for en typisk uge?
  • Er du interesseret i at holde op med at ryge inden for de næste 30 dage?
  • Deltager du i øjeblikket i et andet rygestopprogram eller tager du nogen form for medicin for at holde op med at ryge?
  • Deltager et husstandsmedlem i denne undersøgelse?
  • Er du gravid, ammer eller planlægger du at blive gravid i det næste år?
  • Planlægger du at flytte fra din nuværende adresse inden for de følgende seks måneder?
  • Har du en aktiv mobiltelefon med ubegrænset tekstbeskedfunktion?
  • Er du villig til at komme til 2 studiebesøg, i begyndelsen og 6 måneder, og få mindst 1 telefonopkald mellem besøgene?
  • Ved du, hvordan man sender/læser tekstbeskeder?
  • Er deltageren KVALIFICAT? Hvis IKKE BERETNINGER, udfyld demografiske oplysninger. Hvis BERETNINGER, udfyld kontaktoplysninger.

Ekskluderingskriterier:

  • Inkluder planer om at flytte fra New Jersey inden for de næste 6 måneder
  • Hvis et andet husstandsmedlem meldte sig ind i undersøgelsen.
  • Hvis svarene nej til ethvert spørgsmål i berettigelsesformularen.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Decídetext-programmet
Deltagerne vil modtage en tablet-baseret interaktiv undervisningssession, 6 måneders sms-baseret rådgivning, som inkluderer opfordringer til at få adgang til gratis farmakoterapi.
Decídetext-deltagere vil blive dirigeret til den tablet-baserede software. Deltagerne vil modtage en interaktiv undervisningssession, der vil lede dem gennem sproglig, kulturelt relevant information om rygestop, indsamling af grundlæggende rygehistoriedata og valg/planer om at forberede sig på at holde op. Stopplaner omfatter: 1) valg af stopdato, 2) NRT-præference, 3) plan om at fjerne rygesignaler, 4) identifikation af triggersituationer og 5) valg af foreslåede mestringsstrategier. Deltagerdata og valg bruges til at generere en udskrevet 1-sides individualiseret behandlingsplan. Tabletkomponenter, vurderingselementer, lydfortælling, korte multimedie-instruktionsvideoklip og den udskrevne behandlingsplan er blevet udviklet til at imødegå niveauer med lav læsefærdighed.
Aktiv komparator: Standard Care Control
Deltagerne vil modtage en tilpasset version af standard trykt rygestop undervisningsmateriale fra American Cancer Society og National Cancer Institute, som omfatter information om sundhedsrisici ved rygning, fordele og strategier for at holde op og adgang til gratis farmakoterapi ved at ringe til et gratis nummer .
Undervisningsmateriale leveret som foreslået af American Cancer Society og National Cancer Institute

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cotinin-verificeret 7-dages punktprævalens ved 6 måneder.
Tidsramme: 6 måneder
Deltagere, der stopper, vil foretage et kotinin-verificeret 7-dages prævalenskontrol ved 6. måned.
6 måneder

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
12 ugers selvrapportering
Tidsramme: 12 uger
Deltagere i begge tilstande vil gennemføre opfølgende vurdering ved afslutningen af ​​behandlingen efter 12 uger.
12 uger

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ana Paula Cupertino, PhD, University of Rochester

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.

Generelle publikationer

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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)

1. september 2018

Primær færdiggørelse (Faktiske)

8. september 2021

Studieafslutning (Faktiske)

8. september 2021

Datoer for studieregistrering

Først indsendt

2. juli 2018

Først indsendt, der opfyldte QC-kriterier

2. juli 2018

Først opslået (Faktiske)

13. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. april 2024

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2024

Sidst verificeret

1. april 2024

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