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Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial) (PORTSSS)

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ClinicalTrials.gov Identifier: NCT00775944
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Sponsor:
Collaborator:
Department of Health, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Tobacco Smoking
Interventions Behavioral: Proactive telephone support
Behavioral: Reactive (standard) telephone support
Drug: Offer of voucher for cost-free Nicotine Replacement Therapy
Enrollment 2591
Recruitment Details Participants were recruited between February 2009 and January 2010. 2591 participants were randomised to one of the four treatment groups. Of these, 56 withdrew consent after being randomised and were not included in analyses.
Pre-assignment Details  
Arm/Group Title Standard Support Standard Support & Offer of NRT Proactive Telephone Support Proactive Support & Offer of NRT
Hide Arm/Group Description Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy Proactive support & advice to obtain nicotine addiction treatment Proactive telephone support and offer of voucher for cost free NRT
Period Title: Overall Study
Started 648 647 648 648
Completed 633 [1] 638 [2] 632 [3] 632 [3]
Not Completed 15 9 16 16
[1]
15 participants withdrew consent
[2]
9 participants withdrew consent
[3]
16 participants withdrew consent
Arm/Group Title Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT Total
Hide Arm/Group Description Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment Proactive support & advice to obtain nicotine addiction treatment Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy Proactive telephone support and offer of voucher for cost free NRT Total of all reporting groups
Overall Number of Baseline Participants 648 648 647 648 2591
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 648 participants 648 participants 647 participants 648 participants 2591 participants
40.3  (14.5) 39.7  (14.8) 38.6  (14.8) 39.6  (14.1) 39.6  (14.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 648 participants 648 participants 647 participants 648 participants 2591 participants
< 18 years 12 14 13 11 50
18-64 years 569 562 564 575 2270
>=65 years 33 41 44 31 149
Unknown 34 31 26 31 122
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 648 participants 648 participants 647 participants 648 participants 2591 participants
Female 328 321 350 356 1355
Male 293 301 275 268 1137
Unknown 27 26 22 24 99
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 648 participants 648 participants 647 participants 648 participants 2591 participants
648 648 647 648 2591
1.Primary Outcome
Title Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.
Hide Description 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.
Time Frame 6 months from participant's quit date
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised cases
Arm/Group Title Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Hide Arm/Group Description:
Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
Proactive support & advice to obtain nicotine addiction treatment
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Proactive telephone support and offer of voucher for cost free NRT
Overall Number of Participants Analyzed 648 648 647 648
Measure Type: Number
Unit of Measure: participants
127 124 114 104
2.Secondary Outcome
Title Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.
Hide Description The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.
Time Frame Measured 6 months after participant's quit date
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Hide Arm/Group Description:
Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
Proactive support & advice to obtain nicotine addiction treatment
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Proactive telephone support and offer of voucher for cost free NRT
Overall Number of Participants Analyzed 648 648 647 648
Measure Type: Number
Unit of Measure: participants
62 57 42 39
3.Secondary Outcome
Title Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months
Hide Description Participants had to report not smoking in the three months prior to outcome ascertainment.
Time Frame Measured at 6 months after participant's quit date
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised cases
Arm/Group Title Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Hide Arm/Group Description:
Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
Proactive support & advice to obtain nicotine addiction treatment
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Proactive telephone support and offer of voucher for cost free NRT
Overall Number of Participants Analyzed 648 648 647 648
Measure Type: Number
Unit of Measure: participants
102 114 100 85
4.Secondary Outcome
Title Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month
Hide Description 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.
Time Frame Measured at 1 month after participant's quit date
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised cases
Arm/Group Title Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Hide Arm/Group Description:
Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
Proactive support & advice to obtain nicotine addiction treatment
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Proactive telephone support and offer of voucher for cost free NRT
Overall Number of Participants Analyzed 648 648 647 648
Measure Type: Number
Unit of Measure: participants
257 263 276 244
5.Secondary Outcome
Title Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month
Hide Description Participants had to report not smoking for 7 or more days prior to outcome ascertainment.
Time Frame Measured at 1 month after participant's quit date
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomised cases
Arm/Group Title Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Hide Arm/Group Description:
Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
Proactive support & advice to obtain nicotine addiction treatment
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Proactive telephone support and offer of voucher for cost free NRT
Overall Number of Participants Analyzed 648 648 647 648
Measure Type: Number
Unit of Measure: participants
215 202 223 191
6.Secondary Outcome
Title Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months
Hide Description As title
Time Frame Measured 6 months after participant's quit date
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Health Status at 6 Months EuroQol 5D (EQ5D)
Hide Description This is a generic measure of health status used in health economic analyses.
Time Frame Measured 6 months after participant's quit date
Outcome Measure Data Not Reported
8.Secondary Outcome
Title 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.)
Hide Description Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.
Time Frame Measured 6 months after participant's quit date
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and/or other [non-serious] adverse events were not collected/assessed
 
Arm/Group Title Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Hide Arm/Group Description Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment Proactive support & advice to obtain nicotine addiction treatment Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy Proactive telephone support and offer of voucher for cost free NRT
All-Cause Mortality
Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Standard Support Proactive Telephone Support Standard Support & Offer of NRT Proactive Support & Offer of NRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Graeme Docherty
Organization: University of Nottingham
Phone: 01158321380
Publications:
Tobacco Advisory Group of the Royal College of Physicians. Nicotine addiction in Britain. London: Royal College of Physicians of London, 2000.
Hughes J, Stead L, Lancaster. Antidepressants for smoking cessation. Cochrane Database of Systematic Reviews 2000;Issue 4, 2000.
Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation (Cochrane Review). The Cochrane Library, Issue 4, Chichester, UK: John Wiley & Sons, Ltd, 2003.
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT00775944     History of Changes
Other Study ID Numbers: 08118
First Submitted: October 17, 2008
First Posted: October 20, 2008
Results First Submitted: July 25, 2012
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012