Clinical trial NCT00775944: Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)
Official title: Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Smoking
Keywords: Tobacco
Cigarette
Smoking
Counselling
Nicotine Replacement Therapy
Telephone
Quitline
Helpline
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Department of Health, United Kingdom
First posted: 2008-10-20
Enrollment: 2591
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.
timeFrame: 6 months from participant's quit date
Secondary outcomes:
measure: Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.
timeFrame: Measured 6 months after participant's quit date
measure: Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months
timeFrame: Measured at 6 months after participant's quit date
measure: Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month
timeFrame: Measured at 1 month after participant's quit date
measure: Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month
timeFrame: Measured at 1 month after participant's quit date
measure: Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months
timeFrame: Measured 6 months after participant's quit date
measure: Health Status at 6 Months EuroQol 5D (EQ5D)
timeFrame: Measured 6 months after participant's quit date
measure: 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.)
timeFrame: Measured 6 months after participant's quit date
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Tim Coleman, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ferguson J, Docherty G, Bauld L, Lewis S, Lorgelly P, Boyd KA, McEwen A, Coleman T. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial. BMJ. 2012 Mar 23;344:e1696. doi: 10.1136/bmj.e1696.
citation: Coleman T, McEwen A, Bauld L, Ferguson J, Lorgelly P, Lewis S. Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial. Trials. 2009 Apr 28;10:26. doi: 10.1186/1745-6215-10-26.