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Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient

17. juni 2015 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

1548

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • The University of Alabama at Birmingham - Lung Health Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Usual Care
Standard smoking cessation information provided to all hospitalized patients as part of discharge packet.
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.
Andre navn:
  • Adferdsrådgivning
  • Tobacco Treatment
  • Computer-Assisted Treatment
Eksperimentell: 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.
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.
Andre navn:
  • Adferdsrådgivning
  • Tobacco Treatment
  • Computer-Assisted Treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Smoking abstinence
Tidsramme: 6 months
Biochemically-verified (cotinine) and self-reported tobacco abstinence
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Smoking abstinence
Tidsramme: 3 and 12 months
self-reported tobacco abstinence
3 and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Kathleen F Harrington, PhD, MPH, The University of Alabama at Birmingham

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2011

Primær fullføring (Faktiske)

1. september 2014

Studiet fullført (Faktiske)

1. november 2014

Datoer for studieregistrering

Først innsendt

12. januar 2011

Først innsendt som oppfylte QC-kriteriene

13. januar 2011

Først lagt ut (Anslag)

14. januar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. juni 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juni 2015

Sist bekreftet

1. juni 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 1U01DA031515 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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