Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial) (PORTSSS)
26 septembre 2012 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
2591
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Nottingham, Royaume-Uni, NG5 1PB
- University of Nottingham
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
16 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
Autres noms:
|
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Comparateur actif: 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.
Autres noms:
|
|
Comparateur actif: Standard support & offer NRT
Reactive telephone support (i.e.
Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
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.
Autres noms:
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Autres noms:
|
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Comparateur actif: 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.
Autres noms:
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: Measured 6 months after participant's quit date
|
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.)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Tim Coleman, MB ChB, University of Nottingham
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2009
Achèvement primaire (Réel)
1 février 2010
Achèvement de l'étude (Réel)
1 septembre 2010
Dates d'inscription aux études
Première soumission
17 octobre 2008
Première soumission répondant aux critères de contrôle qualité
17 octobre 2008
Première publication (Estimation)
20 octobre 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 octobre 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 septembre 2012
Dernière vérification
1 septembre 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 08118
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