- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03586596
Mobilstopstøtte til Latino-rygere
Beslutningstekst: Mobilstopstøtte til Latino-rygere
Studieoversigt
Status
Betingelser
Intervention / Behandling
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
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack Meridian Health - Hackensack University Medical Center
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
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
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 |
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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.
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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.
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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 .
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Undervisningsmateriale leveret som foreslået af American Cancer Society og National Cancer Institute
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cotinin-verificeret 7-dages punktprævalens ved 6 måneder.
Tidsramme: 6 måneder
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Deltagere, der stopper, vil foretage et kotinin-verificeret 7-dages prævalenskontrol ved 6. måned.
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6 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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12 ugers selvrapportering
Tidsramme: 12 uger
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Deltagere i begge tilstande vil gennemføre opfølgende vurdering ved afslutningen af behandlingen efter 12 uger.
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12 uger
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ana Paula Cupertino, PhD, University of Rochester
Publikationer og nyttige links
Generelle publikationer
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