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

University of Nottingham

Status and phase: Completed; Phase 4

Conditions: Tobacco Smoking

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00775944

08118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,591 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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2,591 participants in 4 patient groups

Standard support

Active Comparator group

Description:

Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment

Treatment:

Behavioral: Reactive (standard) telephone support

Proactive telephone support

Active Comparator group

Description:

Proactive support \& advice to obtain nicotine addiction treatment

Treatment:

Behavioral: Proactive telephone support

Standard support & offer NRT

Active Comparator group

Description:

Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy

Treatment:

Drug: Offer of voucher for cost-free Nicotine Replacement Therapy

Behavioral: Reactive (standard) telephone support

Proactive support & offer NRT

Active Comparator group

Description:

Proactive telephone support and offer of voucher for cost free NRT

Treatment:

Drug: Offer of voucher for cost-free Nicotine Replacement Therapy

Behavioral: Proactive telephone support