Clinical trial NCT00775944
Conditions: Tobacco Smoking
Keywords: Tobacco Cigarette Smoking Counselling Nicotine Replacement Therapy Telephone Quitline Helpline
Sponsor: University of Nottingham
Start date: 2009-02-01; Completion date: 2010-09-01
Enrollment: 2591 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

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.

Arms: arm 1: Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment arm 2: Proactive support \& advice to obtain nicotine addiction treatment arm 3: Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy arm 4: Proactive telephone support and offer of voucher for cost free NRT
Interventions: intervention 1: Proactive telephone support intervention 2: Reactive (standard) telephone support intervention 3: Offer of voucher for cost-free Nicotine Replacement Therapy
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone

Protocol documents: