- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01277250
Web-based Smoking Cessation Intervention: Transition From Inpatient to Outpatient
keskiviikko 17. kesäkuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
1548
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Alabama
-
Birmingham, Alabama, Yhdysvallat, 35294
- The University of Alabama at Birmingham - Lung Health Center
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
19 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Muut: 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.
Muut nimet:
|
|
Kokeellinen: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Smoking abstinence
Aikaikkuna: 6 months
|
Biochemically-verified (cotinine) and self-reported tobacco abstinence
|
6 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Smoking abstinence
Aikaikkuna: 3 and 12 months
|
self-reported tobacco abstinence
|
3 and 12 months
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Kathleen F Harrington, PhD, MPH, The University of Alabama at Birmingham
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
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Ensisijainen valmistuminen (Todellinen)
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Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 12. tammikuuta 2011
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 13. tammikuuta 2011
Ensimmäinen Lähetetty (Arvio)
Perjantai 14. tammikuuta 2011
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 19. kesäkuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Viimeksi vahvistettu
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 1U01DA031515 (Yhdysvaltain NIH-apuraha/sopimus)
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