Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline
Overview
- Phase
- Phase 4
- Intervention
- Reactive (standard) telephone support
- Conditions
- Tobacco Smoking
- Sponsor
- University of Nottingham
- Enrollment
- 2591
- Locations
- 1
- Primary Endpoint
- Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Standard support
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
Intervention: Reactive (standard) telephone support
Proactive telephone support
Proactive support \& advice to obtain nicotine addiction treatment
Intervention: Proactive telephone support
Standard support & offer NRT
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Intervention: Reactive (standard) telephone support
Standard support & offer NRT
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
Intervention: Offer of voucher for cost-free Nicotine Replacement Therapy
Proactive support & offer NRT
Proactive telephone support and offer of voucher for cost free NRT
Intervention: Proactive telephone support
Proactive support & offer NRT
Proactive telephone support and offer of voucher for cost free NRT
Intervention: Offer of voucher for cost-free Nicotine Replacement Therapy
Outcomes
Primary Outcomes
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
- Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months(Measured 6 months after participant's quit date)
- Health Status at 6 Months EuroQol 5D (EQ5D)(Measured 6 months after participant's quit date)
- 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)
- Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months(Measured at 6 months after participant's quit date)
- Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month(Measured at 1 month after participant's quit date)
- 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)
- 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)