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

Phase 4

Completed

Conditions: Tobacco Smoking

Interventions: Behavioral: Proactive telephone support
Behavioral: Reactive (standard) telephone support
Drug: Offer of voucher for cost-free Nicotine Replacement Therapy

Registration Number: NCT00775944

Lead Sponsor: University of Nottingham

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2591

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 & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Proactive telephone support	Proactive telephone support	Proactive support \& advice to obtain nicotine addiction treatment
Standard support & offer NRT	Reactive (standard) telephone support	Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Standard support & offer NRT	Offer of voucher for cost-free Nicotine Replacement Therapy	Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Proactive support & offer NRT	Proactive telephone support	Proactive telephone support and offer of voucher for cost free NRT
Standard support	Reactive (standard) telephone support	Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
Proactive support & offer NRT	Offer of voucher for cost-free Nicotine Replacement Therapy	Proactive telephone support and offer of voucher for cost free NRT

Primary Outcome Measures

Name	Time	Method
Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.	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 Outcome Measures

Name	Time	Method
Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.	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	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	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	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	Measured 6 months after participant's quit date	As title
Health Status at 6 Months EuroQol 5D (EQ5D)	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.)	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.