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Completed

NCT Number: NCT00775944

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

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.

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Key information

Conditions

Tobacco Smoking Behavior Smoking Tobacco Use

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Nottingham

Nottingham, NG5 1PB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proactive telephone support

Behavioral

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

Reactive (standard) telephone support

Behavioral

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

Offer of voucher for cost-free Nicotine Replacement Therapy

Drug

Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone

Other names: NRT

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Department of Health, United Kingdom

Registry information

Official study title

Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline

Acronym: PORTSSS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 20, 2008
Registry last updated
Oct 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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