- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04623736
Smartphone Application Smoking Cessation Study
Assessment of Smoking Cessation in a Publicly Available Cessation Smartphone Application
Studieoversigt
Detaljeret beskrivelse
Cigarette smoking is the leading cause of preventable death in the U.S. and causes multiple cancers. Approximately 34 million U.S. adults currently smoke cigarettes, but over half of all smokers attempt to quit smoking each year. However, only about 6% quit successfully, in part, because many smokers make unassisted quit attempts, due to the lack of accessibility of cessation programs. Mobile health (mHealth) smoking cessation programs delivered through smartphone applications ('apps') can potentially reach a large number of smokers in the U.S., as 81% of U.S. adult smokers own a smartphone. The National Cancer Institute hosts Smokefree.gov, a suite of free, publicly available smoking cessation resources. In addition to web based and text-messaging resources, Smokefree.gov launched the quitSTART smartphone app in 2013, which is a publicly available smoking cessation app.
Participants in this study will be asked to complete a pre-cessation assessment, then download, install, and try to quit smoking using the smoking cessation smartphone application, quitSTART. Participants will be asked to use quitSTART for 4 weeks. Participants will also be asked to complete online surveys 2 and 4 weeks after the start of the study. To understand how people are using quitSTART, the investigators will collect quitSTART usage data from all participants (for example, how often someone opens quitSTART during the study period and what specific features someone uses).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22904
- University of Virginia
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Cigarette smoker
- Smoked at least 100 cigarettes
- Able to read and speak English
- Owns a smartphone
- 18 years of age or older
- USA resident
Exclusion Criteria:
- Not a cigarette smoker
- has not smoked at least 100 cigarettes
- Not able to read and speak English
- Does not own a smartphone
- Under 18 years of age
- Not a US resident
- Currently pregnant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: quitSTART
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All participants will have access to the Smokefree.gov
Initiative smoking cessation smartphone application, quitSTART.
This app is available, at no cost, to anyone who owns a smartphone and is interested in quitting smoking.
All smokers who download quitSTART are asked to provide basic information about themselves (e.g., age, sex, reason to quit smoking, triggers to smoke, when users typically smoke, how users plan to celebrate success, smoking frequency, age when started smoking regularly, ethnicity, race, cigarettes smoked per day), and set a quit date.
Information about cessation and challenges to help support quitting are available, as well as games and tracking features.
While using the app, users can proactively report cigarette cravings, if they slipped, if they are feeling "down" or feeling "great".
If a user reports a craving, they have the option to mark the timing or location of the craving and request a reminder to resist future cravings at the same time or location.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-reported 7-day smoking abstinence - 2 weeks
Tidsramme: 2 weeks
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"Have you smoked a cigarette (even a puff) in the past 7 days?"
self-reported by the participant
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2 weeks
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Self-reported 7-day smoking abstinence - 4 weeks
Tidsramme: 4 weeks
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"Have you smoked a cigarette (even a puff) in the past 7 days?"
self-reported by the participant
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4 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-reported continuous smoking abstinence - 2 weeks
Tidsramme: 2 weeks
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"In the last two weeks, have you smoked at all?" self-reported by the participant
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2 weeks
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Self-reported continuous smoking abstinence - 4 weeks
Tidsramme: 4 weeks
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"In the last four weeks, have you smoked at all?" self-reported by the participant
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4 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kara P Wiseman, University of Virginia
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 3643
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Kliniske forsøg med quitSTART
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Washington University School of MedicineNational Institute on Drug Abuse (NIDA); The University of Texas Health... og andre samarbejdspartnereRekrutteringNikotinbrugsforstyrrelse | NikotindampningForenede Stater
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University of Massachusetts, WorcesterAfsluttetCigaretrygningForenede Stater