Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial) (PORTSSS)
26. září 2012 aktualizováno: University of Nottingham
Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline
This study shall determine whether or not proactive telephone support for smoking cessation delivered to quitline callers is more effective than standard 'reactive' provision and whether or not the offer of a voucher for a cost free supply of nicotine replacement therapy (NRT) has any additional impact on smoking cessation rates achieved by behavioural interventions.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
There is evidence from other studies that telephone helplines are effective in helping individuals to stop smoking. This study will investigate whether or not two interventions that have been proven effective in other contexts are effective when offered via telephone helplines. The two interventions which will be tested are (1) additional proactive counselling via telephone(several calls from a trained smoking cessation advisor over a certain period) and (2) the offer of Nicotine Replacement Therapy.
This trial will determine whether or not: (1)additional (proactive) telephone support for smoking cessation delivered to users of the National Health Service (NHS)Smoking Helpline, is more effective than standard support given by the helpline, and (2) whether the offer of free Nicotine Replacement Therapy influences rates of stopping smoking in individuals receiving either standard (reactive) or proactive telephone support.
Current smokers over 16 years of age will be recruited by helpline staff with the appropriate consent. Participants will then be randomised into one of four groups:
(i) usual care delivered by the helpline (called the Together Programme) (ii) usual care plus a programme of proactive telephone counselling (iii) usual care AND the offer of Nicotine Replacement Therapy (NRT) (iv) usual helpline support, proactive telephone counselling AND the offer of NRT.
The researchers will not be aware of which group participants have been allocated. The results will determine if the use of proactive telephone counselling is effective in helping individuals to stop smoking. It shall also find out if the offer of NRT medication via a telephone helpline assists individuals in their efforts to stop smoking.
Typ studie
Intervenční
Zápis (Aktuální)
2591
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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Nottingham, Spojené království, NG5 1PB
- University of Nottingham
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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
16 let a starší (Dítě, Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Participants are over 16 and will need to agree to i) receive counselling ii) to set a quit within two weeks and iii) consent to follow up processes.
Exclusion Criteria:
- Telephonists will not enrol potential participants who are not capable of giving informed consent or who have not got access to a phone contact number to which calls can be made by Essentia staff.
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: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Standard support
Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
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Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it.
Ostatní jména:
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Aktivní komparátor: Proactive telephone support
Proactive support & advice to obtain nicotine addiction treatment
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Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls.
Ostatní jména:
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Aktivní komparátor: Standard support & offer NRT
Reactive telephone support (i.e.
Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
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Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it.
Ostatní jména:
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Ostatní jména:
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Aktivní komparátor: Proactive support & offer NRT
Proactive telephone support and offer of voucher for cost free NRT
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Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls.
Ostatní jména:
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.
Časové okno: 6 months from participant's quit date
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Prolonged abstinence was defined as not smoking between a quit date and six months later with minor smoking lapses permitted as long as no more than 5 cigarettes in total were smoked during this period.
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6 months from participant's quit date
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.
Časové okno: Measured 6 months after participant's quit date
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The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.
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Measured 6 months after participant's quit date
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Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months
Časové okno: Measured at 6 months after participant's quit date
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Participants had to report not smoking in the three months prior to outcome ascertainment.
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Measured at 6 months after participant's quit date
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Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month
Časové okno: Measured at 1 month after participant's quit date
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Prolonged abstinence was defined as not smoking between a quit date and one month later; minor lapses were permitted provided no more than 5 cigarettes in total had been smoked.
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Measured at 1 month after participant's quit date
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Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month
Časové okno: Measured at 1 month after participant's quit date
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Participants had to report not smoking for 7 or more days prior to outcome ascertainment.
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Measured at 1 month after participant's quit date
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Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months
Časové okno: Measured 6 months after participant's quit date
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As title
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Measured 6 months after participant's quit date
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Health Status at 6 Months EuroQol 5D (EQ5D)
Časové okno: Measured 6 months after participant's quit date
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This is a generic measure of health status used in health economic analyses.
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Measured 6 months after participant's quit date
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Use of Other NHS Smoking Cessation Interventions (e.g. Uptake of NHS Stop Smoking Services, Use of Other NRT Obtained From General Practitioner (GP) Etc.)
Časové okno: Measured 6 months after participant's quit date
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Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.
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Measured 6 months after participant's quit date
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Tim Coleman, MB ChB, University of Nottingham
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
- Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.
- Platt S, Tannahill A, Watson J, Fraser E. Effectiveness of antismoking telephone helpline: follow up survey. BMJ. 1997 May 10;314(7091):1371-5. doi: 10.1136/bmj.314.7091.1371.
- Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2002;(4):CD000146. doi: 10.1002/14651858.CD000146.
- Silagy C, Mant D, Fowler G, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2000;(3):CD000146. doi: 10.1002/14651858.CD000146.
- Tobacco Advisory Group of the Royal College of Physicians. Going smoke-free: The case for clean air in the home, at work and in public places. London: Royal College of Physicians of London, 2005.
- Tobacco Advisory Group of the Royal College of Physicians. Nicotine addiction in Britain. London: Royal College of Physicians of London, 2000.
- Ashenden R, Silagy C, Weller D. A systematic review of the effectiveness of promoting lifestyle change in general practice. Fam Pract. 1997 Apr;14(2):160-76. doi: 10.1093/fampra/14.2.160.
- Pierce JP, White MM, Gilpin EA. Adolescent smoking decline during California's tobacco control programme. Tob Control. 2005 Jun;14(3):207-12. doi: 10.1136/tc.2004.010116.
- Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.CD000031.
- Ferguson J, Bauld L, Chesterman J, Judge K. The English smoking treatment services: one-year outcomes. Addiction. 2005 Apr;100 Suppl 2:59-69. doi: 10.1111/j.1360-0443.2005.01028.x.
- Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001007. doi: 10.1002/14651858.CD001007.
- Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation (Cochrane Review). The Cochrane Library, Issue 4, Chichester, UK: John Wiley & Sons, Ltd, 2003.
- Coleman T, Lewis S, Hubbard R, Smith C. Impact of contractual financial incentives on the ascertainment and management of smoking in primary care. Addiction. 2007 May;102(5):803-8. doi: 10.1111/j.1360-0443.2007.01766.x.
- Britton J, Lewis S. Trends in the uptake and delivery of smoking cessation services to smokers in Great Britain. J Epidemiol Community Health. 2004 Jul;58(7):569-70. doi: 10.1136/jech.2003.015271. No abstract available.
- Stead LF, Lancaster T, Perera R. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2003;(1):CD002850. doi: 10.1002/14651858.CD002850.
- An LC, Schillo BA, Kavanaugh AM, Lachter RB, Luxenberg MG, Wendling AH, Joseph AM. Increased reach and effectiveness of a statewide tobacco quitline after the addition of access to free nicotine replacement therapy. Tob Control. 2006 Aug;15(4):286-93. doi: 10.1136/tc.2005.014555.
- Ferguson J, Docherty G, Bauld L, Lewis S, Lorgelly P, Boyd KA, McEwen A, Coleman T. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial. BMJ. 2012 Mar 23;344:e1696. doi: 10.1136/bmj.e1696.
- Coleman T, McEwen A, Bauld L, Ferguson J, Lorgelly P, Lewis S. Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial. Trials. 2009 Apr 28;10:26. doi: 10.1186/1745-6215-10-26.
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. února 2009
Primární dokončení (Aktuální)
1. února 2010
Dokončení studie (Aktuální)
1. září 2010
Termíny zápisu do studia
První předloženo
17. října 2008
První předloženo, které splnilo kritéria kontroly kvality
17. října 2008
První zveřejněno (Odhad)
20. října 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
26. října 2012
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. září 2012
Naposledy ověřeno
1. září 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 08118
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 .
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