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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

Tracking Information
First Submitted Date  ICMJE October 17, 2008
First Posted Date  ICMJE October 20, 2008
Results First Submitted Date  ICMJE July 25, 2012
Results First Posted Date  ICMJE October 26, 2012
Last Update Posted Date October 26, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. [ Time Frame: 6 months from participant's quit date ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. [ Time Frame: 6 months from participant's quit date ]
Change History Complete list of historical versions of study NCT00775944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
  • 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 ]
    The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.
  • 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 ]
    Participants had to report not smoking in the three months prior to outcome ascertainment.
  • Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month [ Time Frame: Measured at 1 month after participant's quit date ]
    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.
  • 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 ]
    Participants had to report not smoking for 7 or more days prior to outcome ascertainment.
  • Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months [ Time Frame: Measured 6 months after participant's quit date ]
    As title
  • Health Status at 6 Months EuroQol 5D (EQ5D) [ Time Frame: Measured 6 months after participant's quit date ]
    This is a generic measure of health status used in health economic analyses.
  • 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 ]
    Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
  • Self-reported point prevalence abstinence from smoking for at least 7 days, ascertained at 6 months [ Time Frame: Measured 6 months after participant's quit date ]
  • Self-reported point prevalence abstinence from smoking for at least 7 days, ascertained at 6 months [ Time Frame: Measured 6 months from participant's quit date ]
  • 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 ]
  • Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month [ Time Frame: Measured at 6 months after participant's quit date ]
  • Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month [ Time Frame: Measured at 6 months after participant's quit date ]
  • Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months [ Time Frame: Measured 6 months after participant's quit date ]
  • Health status at 6 months (EQ5D) [ Time Frame: Measured 6 months after participant's quit date ]
  • Use of other NHS smoking cessation interventions (e.g. uptake of NHS Stop Smoking Services, use of other NRT obtained from GP etc.) [ Time Frame: Measured 6 months after participant's quit date ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)
Official Title  ICMJE Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Smoking
Intervention  ICMJE
  • Behavioral: Proactive telephone support
    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.
    Other Names:
    • Telephone
    • Counselling
  • Behavioral: Reactive (standard) telephone support
    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.
    Other Name: Together Programme
  • Drug: Offer of voucher for cost-free Nicotine Replacement Therapy
    Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
    Other Name: NRT
Study Arms  ICMJE
  • Active Comparator: Standard support
    Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
    Intervention: Behavioral: Reactive (standard) telephone support
  • Active Comparator: Proactive telephone support
    Proactive support & advice to obtain nicotine addiction treatment
    Intervention: Behavioral: Proactive telephone support
  • Active Comparator: Standard support & offer NRT
    Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
    Interventions:
    • Behavioral: Reactive (standard) telephone support
    • Drug: Offer of voucher for cost-free Nicotine Replacement Therapy
  • Active Comparator: Proactive support & offer NRT
    Proactive telephone support and offer of voucher for cost free NRT
    Interventions:
    • Behavioral: Proactive telephone support
    • Drug: Offer of voucher for cost-free Nicotine Replacement Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2012)
2591
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2008)
2574
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775944
Other Study ID Numbers  ICMJE 08118
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE Department of Health, United Kingdom
Investigators  ICMJE
Principal Investigator: Tim Coleman, MB ChB University of Nottingham
PRS Account University of Nottingham
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP