Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
17. června 2015 aktualizováno: University of Alabama at Birmingham
This project, "Web-based Smoking Cessation Intervention: transition from inpatient to outpatient," addresses smoking among hospitalized patients, whose rates are higher than among the general population.
Hospitalization offers a unique opportunity to intervene, as it requires temporary abstinence and patients are focused on health concerns.
Hypotheses: A tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home will be effective.
Further, the investigators hypothesize that this approach will be cost-effective.
Specific Aims: 1.
To test the effectiveness of a web-based smoking cessation intervention.
2. To determine the cost-effectiveness of this approach.
Research Design - Methods: A randomized two-arm follow-up design will be used to test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Patients randomized to this arm will be contacted by hospital staff, trained as 'transition coaches,' to engage in Decide2Quit, an interactive web-based program that offers personalized and tailored messages, e-group support, and text messages promoting tobacco abstinence.
All hospitalized patients will receive standardized smoking cessation materials.
As well, physicians can order nicotine replacement therapy via the hospital's electronic order system.
The investigators primary outcome is biologically confirmed and self-reported tobacco abstinence at 6 months follow-up; the investigators will also assess self-reported quit rates at 3 and 12 months and variables hypothesized to predict quit success.
We will measure health care utilization and quality of life to allow testing the cost-effectiveness of this program conducted from the perspective of a hospital, health care payers, patients and society.
Significance of results: At study completion the investigators will know whether imbedding smoking cessation into usual hospital care, with minimal hospital-staff burden, and an interactive web-based tailored intervention program is an effective way to reduce smoking rates among hospitalized patients, and if it is cost-effective.
This program will be an "off the shelf approach that could be disseminated easily.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
1548
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- The University of Alabama at Birmingham - Lung Health Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
19 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- 19 years of age or older
- Current smoker (at least one puff in the last 30 days)
- Regular (at least weekly) email/internet access
- Can read and speak English
- Can communicate well enough to provide meaningful responses to the screening questions and informed consent
- Well enough to participate (provide meaningful responses to the screening questions and informed consent)
- On standard or contact isolation only
- Cognitively able to participate (to provide meaningful responses to the screening questions and informed consent)
- Does not have another household member participating in this study
Exclusion Criteria:
- Under age 19
- Non-smoker
- Cannot read and speak English
- No email/internet access
- Cannot communicate well enough to provide meaningful responses to the screening questions and informed consent
- Too ill to participate (provide meaningful responses to the screening questions and informed consent)
- On isolation precautions other than standard or contact
- Cognitively unable to participate (to provide meaningful responses to the screening questions and informed consent)
- Has another household member participating in this study
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: Usual Care
Standard smoking cessation information provided to all hospitalized patients as part of discharge packet.
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Web-based smoking cessation program that includes a "transition coach" to hospitalized patients who will assist them in quitting as they are discharged from the hospital.
Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay.
Ostatní jména:
|
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Experimentální: Smoking Cessation Program
Web-based program tailored to patients who smoke and are hospitalized.
Program is tailored to participant's specific hospital experience and other characteristics.
E-messages, social support and a "transition coach" are provided to each participant in this condition.
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Web-based smoking cessation program that includes a "transition coach" to hospitalized patients who will assist them in quitting as they are discharged from the hospital.
Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Smoking abstinence
Časové okno: 6 months
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Biochemically-verified (cotinine) and self-reported tobacco abstinence
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6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Smoking abstinence
Časové okno: 3 and 12 months
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self-reported tobacco abstinence
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3 and 12 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Kathleen F Harrington, PhD, MPH, The University of Alabama at Birmingham
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2011
Primární dokončení (Aktuální)
1. září 2014
Dokončení studie (Aktuální)
1. listopadu 2014
Termíny zápisu do studia
První předloženo
12. ledna 2011
První předloženo, které splnilo kritéria kontroly kvality
13. ledna 2011
První zveřejněno (Odhad)
14. ledna 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
19. června 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. června 2015
Naposledy ověřeno
1. června 2015
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 1U01DA031515 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Web-based smoking cessation program
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Prof. Dr. Frank MoorenDokončeno
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)Zatím nenabírámeKarcinom související s kouřením cigaretSpojené státy