- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04623736
Smartphone Application Smoking Cessation Study
Assessment of Smoking Cessation in a Publicly Available Cessation Smartphone Application
Studienübersicht
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Virginia
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Charlottesville, Virginia, Vereinigte Staaten, 22904
- University of Virginia
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-reported 7-day smoking abstinence - 2 weeks
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-reported continuous smoking abstinence - 2 weeks
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Kara P Wiseman, University of Virginia
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 3643
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
Art der unterstützenden IPD-Freigabeinformationen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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