Smoking CessationNCT01893502
Duration of Follow-Up Counselling on Smoking Cessation Outcomes
A study testing Telephone counselling from Quitline in people with Smoking Cessation, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Smoking cessation improves mortality, even in patients with existing smoking-related morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an important method to provide support to smokers and to improve quit rates, especially if three or more calls were used in addition to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Telephone counselling from Quitline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2013to 18 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current smokers among outpatients, including hospital employees, who provide informed consent for enrollment in the smoking cessation program
Who cannot join
- Subjects who decline smoking cessation or who do not provide informed consent
- Subjects who are participating or will be participating in other smoking cessation programs within the next six months
- Subjects who are currently using smoking cessation medications
- Subjects who cannot be followed up for at least six months, for instance, subjects who would be resigning and going overseas within the next six months
- Subjects with language limitations that would impede completion of self-administered questionnaires
- Subjects who are difficult to communicate with over the telephone (e.g. having speech or hearing problems)
Show all 10Show fewer
- Subjects with cognitive impairments that would impede counselling and follow-up
- Subjects with no telephone number
- Subjects who are too sick to receive smoking cessation counselling
- Subjects with limited life expectancy (e.g. metastatic cancer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoke Free Randomized Controlled Trial
Smoking cessation improves mortality, even in patients with existing smoking-related morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an important method to provide support to smokers and to improve quit rates, especially if three or more calls were used in addition to face-to-face counselling. While it is reasonable to assume that more counselling leads to better smoking cessation outcomes, little evidence exists over the amount of telephone follow-up counselling that is required for optimal and sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is superior to one-month of weekly telephone follow-up.
- Conditions
- Smoking Cessation
- Being tested
- Telephone counselling from Quitline
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone counselling from QuitlineBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Participants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for one month Receives: Behavioral: Telephone counselling from Quitline |
| Group 2 | Active comparator | Participants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for six months Receives: Behavioral: Telephone counselling from Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seven-day point prevalence abstinence
Measured: Six months
Secondary outcomes (1)
Average number of cigarettes smoked per day over the past seven days
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startJun 2013
- Primary completion18 Mar 2016
- Study completion18 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
- Investigators
- Kay C See, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893502
- Sponsor's protocol ID
- 2013/00057
- Status last verified
- Apr 2017
- First submitted
- 2 Jul 2013
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoke Free Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01893502
- Acronym / sponsor ID
- 2013/00057
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 18 Mar 2016 (actual)
- Study completion
- 18 Mar 2016 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking cessation improves mortality, even in patients with existing smoking-related morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an important method to provide support to smokers and to improve quit rates, especially if three or more calls were used in addition to face-to-face counselling. While it is reasonable to assume that more counselling leads to better smoking cessation outcomes, little evidence exists over the amount of telephone follow-up counselling that is required for optimal and sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is superior to one-month of weekly telephone follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: Telephone counselling from QuitlineParticipants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for one month |
| Group 2 | Active comparator | Behavioral: Telephone counselling from QuitlineParticipants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for six months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Current smokers among outpatients, including hospital employees, who provide informed consent for enrollment in the smoking cessation program
Key exclusion criteria (10 listed)
- Subjects who decline smoking cessation or who do not provide informed consent
- Subjects who are participating or will be participating in other smoking cessation programs within the next six months
- Subjects who are currently using smoking cessation medications
- Subjects who cannot be followed up for at least six months, for instance, subjects who would be resigning and going overseas within the next six months
- Subjects with language limitations that would impede completion of self-administered questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone counselling from Quitline | Behavioural | Group 1, Group 2 |
Primary outcome
Seven-day point prevalence abstinence
Time frame: Six months
1 secondary outcome
Average number of cigarettes smoked per day over the past seven days
Time frame: 3, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kay C See, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone counselling from Quitline in people with Smoking Cessation, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seven-day point prevalence abstinence (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.