Tobacco Smoking
Conditions
Keywords
Tobacco, Cigarette, Smoking, Counselling, Nicotine Replacement Therapy, Telephone, Quitline, Helpline
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.
Interventions
BEHAVIORALProactive 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.
BEHAVIORALReactive (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.
DRUGOffer of voucher for cost-free Nicotine Replacement Therapy
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Sponsors
Department of Health, United Kingdom
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months | Measured 6 months after participant's quit date | As title |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited between February 2009 and January 2010. 2591 participants were randomised to one of the four treatment groups. Of these, 56 withdrew consent after being randomised and were not included in analyses.
Participants by arm
| Arm | Count |
|---|---|
| Standard Support Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment | 648 |
| Proactive Telephone Support Proactive support & advice to obtain nicotine addiction treatment | 648 |
| Standard Support & Offer of NRT Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy | 647 |
| Proactive Support & Offer of NRT Proactive telephone support and offer of voucher for cost free NRT | 648 |
| Total | 2,591 |
Baseline characteristics
| Characteristic | Proactive Telephone Support | Standard Support & Offer of NRT | Standard Support | Proactive Support & Offer of NRT | Total |
|---|---|---|---|---|---|
| Age Continuous | 39.7 years STANDARD_DEVIATION 14.8 | 38.6 years STANDARD_DEVIATION 14.8 | 40.3 years STANDARD_DEVIATION 14.5 | 39.6 years STANDARD_DEVIATION 14.1 | 39.6 years STANDARD_DEVIATION 14.5 |
| Age, Customized 18-64 years | 562 participants | 564 participants | 569 participants | 575 participants | 2270 participants |
| Age, Customized < 18 years | 14 participants | 13 participants | 12 participants | 11 participants | 50 participants |
| Age, Customized >=65 years | 41 participants | 44 participants | 33 participants | 31 participants | 149 participants |
| Age, Customized Unknown | 31 participants | 26 participants | 34 participants | 31 participants | 122 participants |
| Region of Enrollment United Kingdom | 648 participants | 647 participants | 648 participants | 648 participants | 2591 participants |
| Sex/Gender, Customized Female | 321 participants | 350 participants | 328 participants | 356 participants | 1355 participants |
| Sex/Gender, Customized Male | 301 participants | 275 participants | 293 participants | 268 participants | 1137 participants |
| Sex/Gender, Customized Unknown | 26 participants | 22 participants | 27 participants | 24 participants | 99 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.
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.
Time frame: 6 months from participant's quit date
Population: All randomised cases
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Support | Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. | 127 participants |
| Proactive Telephone Support | Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. | 124 participants |
| Standard Support & Offer of NRT | Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. | 114 participants |
| Proactive Support & Offer of NRT | Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. | 104 participants |
Secondary
Health Status at 6 Months EuroQol 5D (EQ5D)
This is a generic measure of health status used in health economic analyses.
Time frame: Measured 6 months after participant's quit date
Secondary
Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months
As title
Time frame: Measured 6 months after participant's quit date
Secondary
Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months
Participants had to report not smoking in the three months prior to outcome ascertainment.
Time frame: Measured at 6 months after participant's quit date
Population: All randomised cases
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Support | Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months | 102 participants |
| Proactive Telephone Support | Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months | 114 participants |
| Standard Support & Offer of NRT | Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months | 100 participants |
| Proactive Support & Offer of NRT | Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months | 85 participants |
Secondary
Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month
Participants had to report not smoking for 7 or more days prior to outcome ascertainment.
Time frame: Measured at 1 month after participant's quit date
Population: All randomised cases
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Support | Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month | 215 participants |
| Proactive Telephone Support | Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month | 202 participants |
| Standard Support & Offer of NRT | Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month | 223 participants |
| Proactive Support & Offer of NRT | Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month | 191 participants |
Secondary
Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.
The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.
Time frame: Measured 6 months after participant's quit date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Support | Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation. | 62 participants |
| Proactive Telephone Support | Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation. | 57 participants |
| Standard Support & Offer of NRT | Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation. | 42 participants |
| Proactive Support & Offer of NRT | Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation. | 39 participants |
Secondary
Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month
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.
Time frame: Measured at 1 month after participant's quit date
Population: All randomised cases
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Support | Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month | 257 participants |
| Proactive Telephone Support | Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month | 263 participants |
| Standard Support & Offer of NRT | Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month | 276 participants |
| Proactive Support & Offer of NRT | Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month | 244 participants |
Secondary
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.)
Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.
Time frame: Measured 6 months after participant's quit date