Smoking CessationQuit&WinNCT01495689
Smoking Cessation With the Ottawa Model and SmartCard in Out-patient Respirology Clinic Setting
A study testing Ottawa Model with SmartCard in people with Smoking Cessation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Cigarette smoking is the most harmful and quitting smoking is very difficult. Despite quitting, it is very difficult to stay quit for long term. In Ottawa the investigators are very lucky to have designed and developed the Ottawa Model for Smoking Cessation ("Ottawa Model"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Ottawa Model with SmartCard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult >18 years of age attending Respirology Clinic at the Ottawa General hospital
- Current smokers (anyone who had smoked any form of tobacco in the 6 months prior to the clinic visit)
- Willing to set quit dates in next 30 days
Who cannot join
- Subjects with less than 2 year life expectancy (end stage cancer, end stage lung or heart disease etc) and/or receiving palliative care
- Not willing to sign consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Control Trial of Smoking Cessation Using The Ottawa Model With the SmartCard in Out-patient Respirology Clinic Setting
Cigarette smoking is the most harmful and quitting smoking is very difficult. Despite quitting, it is very difficult to stay quit for long term. In Ottawa the investigators are very lucky to have designed and developed the Ottawa Model for Smoking Cessation ("Ottawa Model"). This project is an end result of pain staking research. The Ottawa Model has been implemented very successfully to the hospitalized patients and has shown very promising results of higher quitting rates.
Our objective is to modify the Ottawa Model to suit the needs of patients attending out-patient respirology clinics. The investigators aim to apply the modified Ottawa Model along with the SmartCard to the adult smokers who attend the investigators out-patient Respirology clinic at the Ottawa Hospital.
Read more
The investigators aim to train a nurse in clinical aspects and implementation of the protocols related to the Ottawa Model. The trained nurse will contact the smokers attending the clinic. Those subjects willing to participate in this study will be divided in to two groups. One group of subjects will get counseling and SmartCard on the day of the clinic and follow-up phone calls. The SmartCard is worth $110 toward the purchase of quit smoking medications (i.e. nicotine patch/gum, varenicline, or bupropion). The subjects can re-deem the card at the investigators hospital pharmacy. Those in the control group will be followed-up as the investigators are currently doing i.e. with standard smoking cessation counseling from the clinic physician and the nurse, +/- prescription for smoking cessation aids without access to the study nurse and the extra counseling or SmartCard. The investigators aim to find increased quitting rates in the group getting on-site access to the smoking cessation aids with the Smartcard and counseling.
There are no studies implementing the Ottawa Model along with the SmartCard in out-patient respirology setting so far. The Ottawa Model has proven to be very successful in the in-patient subjects. Thus, the investigators believe, the investigators can modify the Ottawa Model and make it fit the out-patient Respirology setting and increase the quitting rates.
Read the detailed description
Design: Parallel group randomized control trial Method: All adult current smokers attending respirology clinic at the Ottawa General Hospital will be approached to participate. Concealed random allocation will be done if the subject is willing and signed the written informed consent. Experimental arm will receive counseling on site enrollment in the Ottawa Model of Smoking Cessation which includes IVR automated telephone follow-up and will receive a SmartCard worth $110 towards purchase of smoking cessation aids. Usual care arm will receive current usual care in our clinic i.e. strong physician advice, +/- prescription for smoking cessation aids if requested or willing.
As a priori, a third arm was added to the parent study entitled, "A PILOT IMPLEMENTATION OF BUDDHIST MINDFULNESS TRAINING COMBINED WITH THE OTTAWA MODEL FOR SMOKING CESSATION IN AN OUT-PATIENT RESPIROLOGY CLINIC SETTING". For this arm, research ethics board approval was sought and 10 participants were approached.
- Conditions
- Smoking Cessation
- Being tested
- Ottawa Model with SmartCard, Usual care
- Keywords
- Smoking Cessation, respirology Out-patient setting, SmartCard
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ottawa Model with SmartCardBehavioural
Also called Ottawa Model of Smoking Cessation and SmartCard
On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Usual careBehavioural
Also called Usual care as per current practice
Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing Receives: Behavioral: Usual care |
| Ottawa Model with SmartCard | Experimental | On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids Receives: Behavioral: Ottawa Model with SmartCard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.
The primary outcome will be measured at 26 weeks: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) self reported continuous abstinence since randomization. Participants who will not be available for follow-up will be considered smokers. At the 26 week follow-up, all patients who report being abstinent from smoking will have their smoking status confirmed by measurement of a CO sample. If any CO will be >10 ppm, the subject will be considered a smoker.
Measured: 26 weeks
Self-reported Smoking Status
Self-reported smoking status was the primary indicator of effectiveness and was obtained at 26-52 weeks. Participants were asked to respond "yes" or "no" to the question "Do you still smoke?"
Measured: 52 weeks
Secondary outcomes (1)
Rate of Recruitment and Retention
Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation
- Responsible party
- Principal investigator, Smita Pakhale, Ottawa Hospital Research Institute
- Investigators
- Smita Pakhale, MD, FRCPC, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495689
- Sponsor's protocol ID
- OHRI
- Acronym
- Quit&Win
- Status last verified
- May 2023
- First submitted
- 16 Dec 2011
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Control Trial of Smoking Cessation Using The Ottawa Model With the SmartCard in Out-patient Respirology Clinic Setting
- ClinicalTrials.gov ID
- NCT01495689
- Acronym / sponsor ID
- Quit&Win / OHRI
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, respirology Out-patient setting, SmartCard
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cigarette smoking is the most harmful and quitting smoking is very difficult. Despite quitting, it is very difficult to stay quit for long term. In Ottawa the investigators are very lucky to have designed and developed the Ottawa Model for Smoking Cessation ("Ottawa Model"). This project is an end result of pain staking research. The Ottawa Model has been implemented very successfully to the hospitalized patients and has shown very promising results of higher quitting rates.
Our objective is to modify the Ottawa Model to suit the needs of patients attending out-patient respirology clinics. The investigators aim to apply the modified Ottawa Model along with the SmartCard to the adult smokers who attend the investigators out-patient Respirology clinic at the Ottawa Hospital.
The investigators aim to train a nurse in clinical aspects and implementation of the protocols related to the Ottawa Model. The trained nurse will contact the smokers attending the clinic. Those subjects willing to participate in this study will be divided in to two groups. One group of subjects will get counseling and SmartCard on the day of the clinic and follow-up phone calls. The SmartCard is worth $110 toward the purchase of quit smoking medications (i.e. nicotine patch/gum, varenicline, or bupropion). The subjects can re-deem the card at the investigators hospital pharmacy. Those in the control group will be followed-up as the investigators are currently doing i.e. with standard smoking cessation counseling from the clinic physician and the nurse, +/- prescription for smoking cessation aids without access to the study nurse and the extra counseling or SmartCard. The investigators aim to find increased quitting rates in the group getting on-site access to the smoking cessation aids with the Smartcard and counseling.
There are no studies implementing the Ottawa Model along with the SmartCard in out-patient respirology setting so far. The Ottawa Model has proven to be very successful in the in-patient subjects. Thus, the investigators believe, the investigators can modify the Ottawa Model and make it fit the out-patient Respirology setting and increase the quitting rates.
Detailed description
Design: Parallel group randomized control trial Method: All adult current smokers attending respirology clinic at the Ottawa General Hospital will be approached to participate. Concealed random allocation will be done if the subject is willing and signed the written informed consent. Experimental arm will receive counseling on site enrollment in the Ottawa Model of Smoking Cessation which includes IVR automated telephone follow-up and will receive a SmartCard worth $110 towards purchase of smoking cessation aids. Usual care arm will receive current usual care in our clinic i.e. strong physician advice, +/- prescription for smoking cessation aids if requested or willing.
As a priori, a third arm was added to the parent study entitled, "A PILOT IMPLEMENTATION OF BUDDHIST MINDFULNESS TRAINING COMBINED WITH THE OTTAWA MODEL FOR SMOKING CESSATION IN AN OUT-PATIENT RESPIROLOGY CLINIC SETTING". For this arm, research ethics board approval was sought and 10 participants were approached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual careUsual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing |
| Ottawa Model with SmartCard | Experimental | Behavioral: Ottawa Model with SmartCardOn-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult >18 years of age attending Respirology Clinic at the Ottawa General hospital
- Current smokers (anyone who had smoked any form of tobacco in the 6 months prior to the clinic visit)
- Willing to set quit dates in next 30 days
Key exclusion criteria (2 listed)
- Subjects with less than 2 year life expectancy (end stage cancer, end stage lung or heart disease etc) and/or receiving palliative care
- Not willing to sign consent
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 |
|---|---|---|
| Ottawa Model with SmartCardAlso: Ottawa Model of Smoking Cessation and SmartCardOn-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids | Behavioural | Ottawa Model with SmartCard |
| Usual careAlso: Usual care as per current practiceUsual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing | Behavioural | Usual Care |
Primary outcome
Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.
Time frame: 26 weeks
The primary outcome will be measured at 26 weeks: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) self reported continuous abstinence since randomization. Participants who will not be available for follow-up will be considered smokers. At the 26 week follow-up, all patients who report being abstinent from smoking will have their smoking status confirmed by measurement of a CO sample. If any CO will be >10 ppm, the subject will be considered a smoker.
Self-reported Smoking Status
Time frame: 52 weeks
Self-reported smoking status was the primary indicator of effectiveness and was obtained at 26-52 weeks. Participants were asked to respond "yes" or "no" to the question "Do you still smoke?"
1 secondary outcome
Rate of Recruitment and Retention
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Smita Pakhale, MD, FRCPC principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ottawa Model with SmartCard in people with Smoking Cessation, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 3 inclusion and 2 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 19 Jan 2024. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks. (time frame: 26 weeks). The study lists 2 primary outcomes in all. 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 19 Jan 2024.