Web and Mobile Smoking Cessation (MobileQuit)
10. februar 2019 opdateret af: Oregon Research Institute
Web and Mobile Smoking Cessation Interventions
This study seeks to develop and then perform a controlled efficacy Randomized Controlled Trial assessing tobacco abstinence of a best-practices Web-based PC-delivered smoking cessation intervention (QuitOnline) compared to a Mobile Smartphone-delivered intervention (MobileQuit).
Study participants are randomized to one of two conditions: a Web Only intervention and the Web+Mobile intervention.
The hypothesis is that the Web+Mobile approach will yield greater efficacy than the Web Only condition.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The primary aims of this project are to:
- Use an iterative formative development process to create two separate Web-based smoking cessation programs (Web+Mobile, Web Only).
- Compare the efficacy of the two smoking cessation programs in terms of tobacco abstinence. The investigators hypothesize that the Web+Mobile condition will be significantly more efficacious in terms of tobacco abstinence than the Web Only condition.
- Evaluate program usage/participant engagement, treatment acceptability, and consumer satisfaction. The investigators hypothesize that both conditions will be acceptable and that the Web+Mobile condition will have significantly greater usage and higher consumer satisfaction than the Web Only condition.
The secondary aims of this proposal are to:
- Evaluate the differences between conditions on ancillary tobacco outcomes. The investigators hypothesize that the participants assigned to the Web+Mobile condition who continue to smoke will nonetheless report a greater decline in the smoking rate and more quit attempts.
- Evaluate predictors and condition moderators of tobacco abstinence. The investigators will conduct exploratory analyses of the association of treatment outcomes to participant characteristics (e.g., baseline smoking rate, nicotine dependence level, partner's tobacco use, prior quitting attempts, prior use of pharmacological adjuncts, and other demographic factors).
- Evaluate putative mechanisms of change. The investigators will test whether change in the putative mechanisms of change (i.e., self-efficacy, program use, use of pharmacological adjuncts) mediate the association between the intervention condition and 3-month sustained abstinence from the 3 month to 6 month assessments.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1266
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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Oregon
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Eugene, Oregon, Forenede Stater, 97403
- Oregon Research Institute
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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
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- ≥ 18 years of age
- Cigarettes are primary tobacco of use
- Smoke ≥ 5 cigs/day for the previous 6 months
- Want to quit in next 14 days
- Use a smartphone and willing to potentially receive/send up to 150 text messages over the six months of the program
- Access to the Internet
- Have a valid personal e-mail address
- Be a U.S. citizen
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Web+Mobile
A best-practices Web-based smoking cessation program integrated with a tailored treatment program delivered using a smartphone application.
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We propose to evaluate the efficacy and acceptability of a Web+Mobile tobacco cessation intervention in a 2-arm Randomized Controlled Trial with 1,271 adult study participants who agree to quit smoking within a pre-specified amount of time.
Participants who meet eligibility criteria will be randomly assigned to either (a) an enhanced Web Only intervention or (b) an enhanced Web+Mobile intervention.
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Aktiv komparator: Web Only
A best-practices Web-based smoking cessation program.
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A Web-based PC-delivered best practices smoking cessation intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment
Tidsramme: Change from enrollment to 3 months and 6 months post enrollment
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Change in all-tobacco abstinence from enrollment to 3 and 6 months.
Measured using 7 day point prevalence.
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Change from enrollment to 3 months and 6 months post enrollment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Program usage, treatment acceptability, consumer satisfaction 3 months post enrollment follow-up
Tidsramme: 3 months post enrollment
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Evaluate program usage of each condition using unobtrusive measures of website visits (both conditions: number, duration, webpages viewed, interactive activities used), use of mobile intervention components (Web+Mobile condition only: number of calls received, number of responses received, extent of data collected), treatment acceptability, and consumer satisfaction
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3 months post enrollment
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Predictors and condition moderators of tobacco abstinence at 6-months follow-up
Tidsramme: Baseline to 6-month follow-up
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Analyses of the association of primary outcomes to participant characteristics (e.g., baseline smoking rate, nicotine dependence level, partner's tobacco use, prior quitting attempts, prior use of pharmacological adjuncts, and other demographic factors).
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Baseline to 6-month follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
Hjælpsomme links
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. februar 2015
Primær færdiggørelse (Faktiske)
1. oktober 2017
Studieafslutning (Faktiske)
31. august 2018
Datoer for studieregistrering
Først indsendt
25. juli 2013
Først indsendt, der opfyldte QC-kriterier
24. september 2013
Først opslået (Skøn)
27. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CA172205-01
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 .