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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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Support Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
Standard Support & Offer of NRT Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Proactive Telephone Support Proactive support & advice to obtain nicotine addiction treatment
Proactive Support & Offer of NRT Proactive telephone support and offer of voucher for cost free NRT

Participant Flow:   Overall Study
    Standard Support   Standard Support & Offer of NRT   Proactive Telephone Support   Proactive Support & Offer of NRT
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



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Support Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
Proactive Telephone Support Proactive support & advice to obtain nicotine addiction treatment
Standard Support & Offer of NRT Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Proactive Support & Offer of NRT Proactive telephone support and offer of voucher for cost free NRT
Total Total of all reporting groups

Baseline Measures
   Standard Support   Proactive Telephone Support   Standard Support & Offer of NRT   Proactive Support & Offer of NRT   Total 
Overall Participants Analyzed 
[Units: Participants]
 648   648   647   648   2591 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.3  (14.5)   39.7  (14.8)   38.6  (14.8)   39.6  (14.1)   39.6  (14.5) 
Age, Customized 
[Units: 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 
Gender, Customized 
[Units: Participants]
         
Female   328   321   350   356   1355 
Male   293   301   275   268   1137 
Unknown   27   26   22   24   99 
Region of Enrollment 
[Units: Participants]
         
United Kingdom   648   648   647   648   2591 


  Outcome Measures

1.  Primary:   Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.   [ Time Frame: 6 months from participant's quit date ]

2.  Secondary:   Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.   [ Time Frame: Measured 6 months after participant's quit date ]

3.  Secondary:   Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months   [ Time Frame: Measured at 6 months after participant's quit date ]

4.  Secondary:   Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month   [ Time Frame: Measured at 1 month after participant's quit date ]

5.  Secondary:   Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month   [ Time Frame: Measured at 1 month after participant's quit date ]

6.  Secondary:   Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months   [ Time Frame: Measured 6 months after participant's quit date ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Health Status at 6 Months EuroQol 5D (EQ5D)   [ Time Frame: Measured 6 months after participant's quit date ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   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.)   [ Time Frame: Measured 6 months after participant's quit date ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: graeme.docherty@nottingham.ac.uk


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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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