Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Smoking |
Behavioral: Proactive telephone support Behavioral: Reactive (standard) telephone support Drug: Offer of voucher for cost-free Nicotine Replacement Therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline |
- Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. [ Time Frame: 6 months from participant's quit date ] [ Designated as safety issue: No ]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.
- Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation. [ Time Frame: Measured 6 months after participant's quit date ] [ Designated as safety issue: No ]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 [ Time Frame: Measured at 6 months after participant's quit date ] [ Designated as safety issue: No ]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 [ Time Frame: Measured at 1 month after participant's quit date ] [ Designated as safety issue: No ]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 [ Time Frame: Measured at 1 month after participant's quit date ] [ Designated as safety issue: No ]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 [ Time Frame: Measured 6 months after participant's quit date ] [ Designated as safety issue: No ]As title
- Health Status at 6 Months EuroQol 5D (EQ5D) [ Time Frame: Measured 6 months after participant's quit date ] [ Designated as safety issue: No ]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.) [ Time Frame: Measured 6 months after participant's quit date ] [ Designated as safety issue: No ]Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.
| Enrollment: | 2591 |
| Study Start Date: | February 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard support
Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
|
Behavioral: Reactive (standard) telephone support
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.
Other Name: Together Programme
|
|
Active Comparator: Proactive telephone support
Proactive support & advice to obtain nicotine addiction treatment
|
Behavioral: Proactive telephone support
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.
Other Names:
|
|
Active Comparator: Standard support & offer NRT
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
Behavioral: Reactive (standard) telephone support
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.
Other Name: Together Programme
Drug: Offer of voucher for cost-free Nicotine Replacement Therapy
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Other Name: NRT
|
|
Active Comparator: Proactive support & offer NRT
Proactive telephone support and offer of voucher for cost free NRT
|
Behavioral: Proactive telephone support
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.
Other Names:
Drug: Offer of voucher for cost-free Nicotine Replacement Therapy
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Other Name: NRT
|
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United Kingdom | |
| University of Nottingham | |
| Nottingham, United Kingdom, NG5 1PB | |
| Principal Investigator: | Tim Coleman, MB ChB | University of Nottingham |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Nottingham |
| ClinicalTrials.gov Identifier: | NCT00775944 History of Changes |
| Other Study ID Numbers: | 08118 |
| Study First Received: | October 17, 2008 |
| Results First Received: | July 25, 2012 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Nottingham:
|
Tobacco Cigarette Smoking Counselling |
Nicotine Replacement Therapy Telephone Quitline Helpline |
Additional relevant MeSH terms:
|
Smoking Habits Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013