Trial Outcomes & Findings for Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial) (NCT NCT00775944)
NCT ID: NCT00775944
Last Updated: 2012-10-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2591 participants
Primary outcome timeframe
6 months from participant's quit date
Results posted on
2012-10-26
Participant Flow
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.
Participant milestones
| Measure |
Standard Support
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
|
Standard Support & Offer of NRT
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
Proactive Telephone Support
Proactive support \& advice to obtain nicotine addiction treatment
|
Proactive Support & Offer of NRT
Proactive telephone support and offer of voucher for cost free NRT
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
648
|
647
|
648
|
648
|
|
Overall Study
COMPLETED
|
633
|
638
|
632
|
632
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
16
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)
Baseline characteristics by cohort
| Measure |
Standard Support
n=648 Participants
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
|
Proactive Telephone Support
n=648 Participants
Proactive support \& advice to obtain nicotine addiction treatment
|
Standard Support & Offer of NRT
n=647 Participants
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
Proactive Support & Offer of NRT
n=648 Participants
Proactive telephone support and offer of voucher for cost free NRT
|
Total
n=2591 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
40.3 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
39.6 years
STANDARD_DEVIATION 14.5 • n=21 Participants
|
|
Age, Customized
< 18 years
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
11 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Age, Customized
18-64 years
|
569 participants
n=5 Participants
|
562 participants
n=7 Participants
|
564 participants
n=5 Participants
|
575 participants
n=4 Participants
|
2270 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
33 participants
n=5 Participants
|
41 participants
n=7 Participants
|
44 participants
n=5 Participants
|
31 participants
n=4 Participants
|
149 participants
n=21 Participants
|
|
Age, Customized
Unknown
|
34 participants
n=5 Participants
|
31 participants
n=7 Participants
|
26 participants
n=5 Participants
|
31 participants
n=4 Participants
|
122 participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
328 participants
n=5 Participants
|
321 participants
n=7 Participants
|
350 participants
n=5 Participants
|
356 participants
n=4 Participants
|
1355 participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
293 participants
n=5 Participants
|
301 participants
n=7 Participants
|
275 participants
n=5 Participants
|
268 participants
n=4 Participants
|
1137 participants
n=21 Participants
|
|
Sex/Gender, Customized
Unknown
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
22 participants
n=5 Participants
|
24 participants
n=4 Participants
|
99 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
648 participants
n=5 Participants
|
648 participants
n=7 Participants
|
647 participants
n=5 Participants
|
648 participants
n=4 Participants
|
2591 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 months from participant's quit datePopulation: All randomised cases
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.
Outcome measures
| Measure |
Standard Support
n=648 Participants
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
|
Proactive Telephone Support
n=648 Participants
Proactive support \& advice to obtain nicotine addiction treatment
|
Standard Support & Offer of NRT
n=647 Participants
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
Proactive Support & Offer of NRT
n=648 Participants
Proactive telephone support and offer of voucher for cost free NRT
|
|---|---|---|---|---|
|
Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.
|
127 participants
|
124 participants
|
114 participants
|
104 participants
|
SECONDARY outcome
Timeframe: Measured 6 months after participant's quit dateThe participant had to report not smoking for at least 7 days prior to the point of outcome assessment.
Outcome measures
| Measure |
Standard Support
n=648 Participants
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
|
Proactive Telephone Support
n=648 Participants
Proactive support \& advice to obtain nicotine addiction treatment
|
Standard Support & Offer of NRT
n=647 Participants
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
Proactive Support & Offer of NRT
n=648 Participants
Proactive telephone support and offer of voucher for cost free NRT
|
|---|---|---|---|---|
|
Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.
|
62 participants
|
57 participants
|
42 participants
|
39 participants
|
SECONDARY outcome
Timeframe: Measured at 6 months after participant's quit datePopulation: All randomised cases
Participants had to report not smoking in the three months prior to outcome ascertainment.
Outcome measures
| Measure |
Standard Support
n=648 Participants
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
|
Proactive Telephone Support
n=648 Participants
Proactive support \& advice to obtain nicotine addiction treatment
|
Standard Support & Offer of NRT
n=647 Participants
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
Proactive Support & Offer of NRT
n=648 Participants
Proactive telephone support and offer of voucher for cost free NRT
|
|---|---|---|---|---|
|
Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months
|
102 participants
|
114 participants
|
100 participants
|
85 participants
|
SECONDARY outcome
Timeframe: Measured at 1 month after participant's quit datePopulation: All randomised cases
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.
Outcome measures
| Measure |
Standard Support
n=648 Participants
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
|
Proactive Telephone Support
n=648 Participants
Proactive support \& advice to obtain nicotine addiction treatment
|
Standard Support & Offer of NRT
n=647 Participants
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
Proactive Support & Offer of NRT
n=648 Participants
Proactive telephone support and offer of voucher for cost free NRT
|
|---|---|---|---|---|
|
Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month
|
257 participants
|
263 participants
|
276 participants
|
244 participants
|
SECONDARY outcome
Timeframe: Measured at 1 month after participant's quit datePopulation: All randomised cases
Participants had to report not smoking for 7 or more days prior to outcome ascertainment.
Outcome measures
| Measure |
Standard Support
n=648 Participants
Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment
|
Proactive Telephone Support
n=648 Participants
Proactive support \& advice to obtain nicotine addiction treatment
|
Standard Support & Offer of NRT
n=647 Participants
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
|
Proactive Support & Offer of NRT
n=648 Participants
Proactive telephone support and offer of voucher for cost free NRT
|
|---|---|---|---|---|
|
Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month
|
215 participants
|
202 participants
|
223 participants
|
191 participants
|
SECONDARY outcome
Timeframe: Measured 6 months after participant's quit dateAs title
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 6 months after participant's quit dateThis is a generic measure of health status used in health economic analyses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 6 months after participant's quit dateParticipants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.
Outcome measures
Outcome data not reported
Adverse Events
Standard Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proactive Telephone Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Support & Offer of NRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proactive Support & Offer of NRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place