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

This study has been completed.
Sponsor:
Collaborator:
Department of Health, United Kingdom
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00775944
First received: October 17, 2008
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Tobacco Smoking
Behavioral: Proactive telephone support
Behavioral: Reactive (standard) telephone support
Drug: Offer of voucher for cost-free Nicotine Replacement Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. [ Time Frame: 6 months from participant's quit date ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    As title

  • Health Status at 6 Months EuroQol 5D (EQ5D) [ Time Frame: Measured 6 months after participant's quit date ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.


Enrollment: 2591
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • Telephone
  • Counselling
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 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
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:
  • Telephone
  • Counselling
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775944

Locations
United Kingdom
University of Nottingham
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
University of Nottingham
Department of Health, United Kingdom
Investigators
Principal Investigator: Tim Coleman, MB ChB University of Nottingham
  More Information

Publications:
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.
Hughes J, Stead L, Lancaster. Antidepressants for smoking cessation. Cochrane Database of Systematic Reviews 2000;Issue 4, 2000.

Additional 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
Study First Received: October 17, 2008
Results First Received: July 25, 2012
Last Updated: September 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Tobacco
Cigarette
Smoking
Counselling
Nicotine Replacement Therapy
Telephone
Quitline
Helpline

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014