Tobacco Tactics Website for Operating Engineers (BCBSM-OE)
17. november 2014 opdateret af: Sonia Duffy, University of Michigan
This is a clustered randomized control trial to test the Tobacco Tactics intervention among Operating Engineers (heavy equipment workers).
The intervention group will be directed to the Tobacco Tactics website, and the control group will be directed to the state supported 1-800 quit-now telephone hotline during routine annual safety training that all Operating Engineers are required to attend.
The web-based quitting intervention includes provision of over-the-counter nicotine replacement therapy and will be followed by nurse email and/or telephone counseling.
It is expected that Operating Engineers who are randomized to the Tobacco Tactics website intervention will have at least equal or greater decreases in smoking at 30-day and 6-month follow-up compared to those randomized to the 1-800-QUIT-NOW quit line.
In addition, the investigators expect to find that Operating Engineers randomized to the Tobacco Tactics website intervention will: a) be able to accomplish tasks; b) be able to accomplish goals with skill and speed; c) be able to operate the system; d) be satisfied with the website; e) access the site repeatedly; and f) spend time on the site during the intervention period.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
232
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan, School of Nursing
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- attending a training session provided by the Operating Engineers Local 324 Education Center
- greater than 18 years of age
- smoked cigarettes in the past month
- interested in participating in a program to quit smoking
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 1-800-QUIT-NOW Telephone Hotline
The control group receives efficacious smoking cessation treatment via the 1-800-QUIT-NOW telephone hotline.
The 1-800-QUIT-NOW hotline is a national program.
The first time smokers call the hotline, they receive a personal coach who assists them in setting a quit date and making an individualized quit plan.
The personal coach also provides on-going support with up to five telephone coaching sessions around the caller's quit date.
|
The control group receives efficacious smoking cessation treatment via the 1-800-QUIT-NOW telephone hotline.
The 1-800-QUIT-NOW hotline is a national program.
The first time smokers call the hotline, they receive a personal coach who assists them in setting a quit date and making an individualized quit plan.
The personal coach also provides on-going support with up to five telephone coaching sessions around the caller's quit date.
|
|
Eksperimentel: Tobacco Tactics Intervention
This intervention contains a website, medications, and nurse counseling.
|
The Tobacco Tactics Web-Based Intervention contains website, medications, and nurse counseling.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quit Rate
Tidsramme: 30-day Follow-Up
|
The investigators will measure 7-day point prevalence abstinence by asking the well validated question, "Have you used any tobacco products (even one puff) in the past 7 days?"
The investigators will also assess harm reduction (ability to quit at all, number of quit attempts, and number of cigarettes smoked per day).
|
30-day Follow-Up
|
|
Quit Rate
Tidsramme: 6-Month Follow-Up
|
The investigators will measure 7-day point prevalence abstinence by asking the well validated question, "Have you used any tobacco products (even one puff) in the past 7 days?"
Smoking status will be confirmed by biochemical verification in the form of urinary cotinine test strips.
The investigators will also assess harm reduction (ability to quit at all, number of quit attempts, and number of cigarettes smoked per day).
|
6-Month Follow-Up
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sonia A Duffy, PhD, RN, University of Michigan
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001188. doi: 10.1002/14651858.CD001188.pub3.
- Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM. Telephone counseling for smoking cessation: rationales and meta-analytic review of evidence. Health Educ Res. 1996 Jun;11(2):243-57. doi: 10.1093/her/11.2.243.
- Fiore MC. US public health service clinical practice guideline: treating tobacco use and dependence. Respir Care. 2000 Oct;45(10):1200-62.
- Solomon LJ, Scharoun GM, Flynn BS, Secker-Walker RH, Sepinwall D. Free nicotine patches plus proactive telephone peer support to help low-income women stop smoking. Prev Med. 2000 Jul;31(1):68-74. doi: 10.1006/pmed.2000.0683.
- Stern F, Haring-Sweeney M. Proportionate mortality among unionized construction operating engineers. Am J Ind Med. 1997 Jul;32(1):51-65. doi: 10.1002/(sici)1097-0274(199707)32:13.0.co;2-u.
- Lee DJ, Fleming LE, McCollister KE, Caban AJ, Arheart KL, LeBlanc WG, Chung-Bridges K, Christ SL, Dietz N, Clark JD 3rd. Healthcare provider smoking cessation advice among US worker groups. Tob Control. 2007 Oct;16(5):325-8. doi: 10.1136/tc.2006.019117.
- Moher M, Hey K, Lancaster T. Workplace interventions for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003440. doi: 10.1002/14651858.CD003440.pub2.
- Lenert L, Munoz RF, Stoddard J, Delucchi K, Bansod A, Skoczen S, Perez-Stable EJ. Design and pilot evaluation of an internet smoking cessation program. J Am Med Inform Assoc. 2003 Jan-Feb;10(1):16-20. doi: 10.1197/jamia.m1128.
- Choi SH, Waltje AH, Ronis DL, Noonan D, Hong O, Richardson CR, Meeker JD, Duffy SA. Web-enhanced tobacco tactics with telephone support versus 1-800-QUIT-NOW telephone line intervention for operating engineers: randomized controlled trial. J Med Internet Res. 2014 Nov 20;16(11):e255. doi: 10.2196/jmir.3375.
- Duffy SA, Ronis DL, Richardson C, Waltje AH, Ewing LA, Noonan D, Hong O, Meeker JD. Protocol of a randomized controlled trial of the Tobacco Tactics website for operating engineers. BMC Public Health. 2012 May 17;12:335. doi: 10.1186/1471-2458-12-335.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2010
Primær færdiggørelse (Faktiske)
1. marts 2013
Studieafslutning (Faktiske)
1. august 2014
Datoer for studieregistrering
Først indsendt
13. maj 2010
Først indsendt, der opfyldte QC-kriterier
13. maj 2010
Først opslået (Skøn)
14. maj 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. november 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. november 2014
Sidst verificeret
1. november 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- N011646 - 1465.RFP
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .