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

September 26, 2012 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

2591

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard support
Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
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 Names:
  • Together Programme
Active Comparator: Proactive telephone support
Proactive support & advice to obtain nicotine addiction treatment
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:
  • Counselling
  • Telephone
Active Comparator: Standard support & offer NRT
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
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 Names:
  • 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 Names:
  • NRT
Active Comparator: Proactive support & offer NRT
Proactive telephone support and offer of voucher for cost free NRT
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:
  • Counselling
  • Telephone
Drug: Offer of voucher for cost-free Nicotine Replacement Therapy
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Other Names:
  • NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months from participant's quit date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured 6 months after 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
Participants had to report not smoking in the three months prior to outcome ascertainment.
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 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.
Measured at 1 month 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 1 month after participant's quit date
Participants had to report not smoking for 7 or more days prior to outcome ascertainment.
Measured at 1 month 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
As title
Measured 6 months after participant's quit date
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.
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 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.
Measured 6 months after participant's quit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Department of Health, United Kingdom

Investigators

  • Principal Investigator: Tim Coleman, MB ChB, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

September 26, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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