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SmokingNCT02701686

A Comparison of the Effectiveness of Two Approaches in Achieving Smoking Abstinence

A study testing quit immediately (QI) and cut down to quit (CDTQ) in people with Smoking, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the effectiveness of negotiating self determination to reduce cigarette consumption. A single-blinded multi-centre randomized controlled is employed. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking
What is being tested?
quit immediately (QI) and cut down to quit (CDTQ)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteHong Kong
Study dates
Jun 2014to Nov 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • aged 18 years or above,
  • smoke at least two cigarettes per day,

Who cannot join

  • those with unstable medical conditions as advised by the doctor in charge,
  • poor cognitive state or mental illness,
  • participation in other smoking cessation programmes or services.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Sai Ying Pun Jockey Club General Out-patient Clinic in Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Comparison of the Effectiveness of Two Approaches (Quit Immediately: QI and Cut Down to Quit: CDTQ) in Achieving Smoking Abstinence Among Patients Having Follow-up in a GOPC: A Pilot Randomized Controlled Trial

The purpose of this study is to test the effectiveness of negotiating self determination to reduce cigarette consumption. A single-blinded multi-centre randomized controlled is employed.

Read the detailed description

Introduction:

A brief intervention with a small to moderate effect size can potentially benefit a large number of smokers and increase smoking cessation within the community if it is carried out routinely in clinical practices by all or most healthcare professionals or people with minimal training. It is also the most cost-effective smoking cessation programme, because no extra or minimal funding is needed to provide the venue, manpower, and other expenses (but incentives or payments to healthcare professionals and follow-up support would be needed). There is no evidence that longer interventions are more effective than shorter interventions. Brief cessation interventions have been shown to be effective with strong evidence from the investigators' randomised controlled trials and in systematic reviews.

The negotiating self-determination to reduce cigarette consumption is guided by social cognitive and self-determination theories. According to social cognitive theory, self-efficacy is an important personal determinant of human behaviour and has been defined as the belief in one's capability to engage in behaviour to solve difficult tasks. This belief influences decisions on whether a certain form of behaviour will be adopted and maintained. Because self-efficacy is built on a successful experience of overcoming challenging tasks, smokers who have more successful experiences in reducing cigarette consumption tend to have higher levels of self-efficacy. Some evidence has shown that a reduction in smoking may lead to greater self-efficacy to resist smoking, which could increase subsequent quitting. According to self-determination theory, autonomy is another influential determinant of behaviours which is emphasized by freedom of choice. Studies have shown that patients having an opportunity to decide on their own treatment may feel more eager to comply with instructions. The subjects in this study will be allowed to select their own schedules of smoking reduction after the negotiation with the counsellor, such as the percentage of smoking reduction over an acceptable period of time. It is anticipated that the subjects will show more willingness to adhere to their own schedule as a result of an increase in autonomy. Moreover, some evidence has shown that autonomy is positively associated with competence; that is, people have greater autonomy demonstrate higher competence in achieving behavioural change. Consequently, autonomy will facilitate their gradual reduction or cessation of smoking. Most importantly, as a result of reducing the cigarette consumption and lowering down the nicotine dependence, it would be much easier for such smokers to further reduce or quit.

Methods:

Chinese patients attending the general out-patient clinics in Hong Kong for routine follow-up visits who fulfil the following inclusion criteria will be invited to participate in the study.

All smoking patients will be approached by a nurse counselors.

Analysis:

Data analysis will be performed using the Statistical Package for Social Science. In particular, we will use inferential statistics (independent-samples t-test and χ2 test) to examine the homogeneity between the QI and CDTQ groups. We will conduct logistic regression analyses to calculate the odds ratio (OR) and 95% confidence interval (CI) for smoking outcomes, i.e. self-reported and biochemical validated quit rates, self-reported smoking reduction rates and number of quit attempts. We will apply mixed between-within subjects analysis of variance (ANOVA) to determine whether CDTQ is more effective than QI in enhancing self-efficacy (perceived importance, difficulty and confidence) for quitting smoking. We shall adopt the principle of intention to treat. Subjects who are lost to follow-up, refuse to participate in biochemical validations, or withdraw from the study are considered unable to quit or reduce smoking. Depending on the amount and distribution of missing data, other methods, e.g. sensitivity analysis and multiple imputation technique will be used if necessary.

Conditions
Smoking
Being tested
quit immediately (QI), cut down to quit (CDTQ)
Keywords
smoking cessation
Medical subject headings
Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quit immediately (QI)Behavioural

    advise to quit immediately using the AWARD model

  • cut down to quit (CDTQ)Behavioural

    advise to reduce cigarette consumption and quit eventally using the AWARD model

Study groups in NCT02701686
Study groupRoleWhat they receive
quit immediately (QI)ExperimentalSubjects in the QI group will receive a smoking cessation booklet plus a brief intervention using the AWARD model: (a) Ask about smoking history, (b) Warn about the high risk, (c) Advise to quit now, as quitting can greatly reduce risks, (d) Refer smokers to a smoking cessation clinic, and (e) Do it again: repeat the intervention during each telephone follow-up. The whole intervention will be limited to less than 1 min or slightly longer if necessary. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the counsellor will congratulate to the subjects who successfully quit smoking, while deliver the same brief intervention as a booster for those who continue to smoke.
Receives: Behavioral: quit immediately (QI)
cut down to quit (CDTQ)ExperimentalSubjects in the CDTQ group will also receive the smoking cessation booklet plus a brief intervention using the AWARD model. Instead of asking them to quit immediately, they will be advised gradually cutting down on their cigarette consumption. Also, the subjects will be provided with an education card that contains reduction strategies and a suggested plan to reduce smoking. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the nurse counsellor will repeat the warning message that one out of two smokers will be killed by smoking, and remind the subjects of their next reduction target. The counsellor will congratulate subjects who quit or reduce smoking on their success. When subjects fail to quit or reduce their cigarette consumption, the counsellor will reinforce the health hazards of continued smoking and the benefits of quitting, and encourage them to try again immediately or in the near future.
Receives: Behavioral: cut down to quit (CDTQ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. self-reported 7-day point prevalence of abstinence

    Measured: 6 months

  2. self-reported 7-day point prevalence of abstinence

    Measured: 12 months

  3. self-reported reduction of ≥ 50% in cigarette consumption

    Measured: 6 months

  4. self-reported reduction of ≥ 50% in cigarette consumption

    Measured: 12 months

Secondary outcomes (6)
  1. biochemically validated abstinence (exhaled CO test & saliva cotinine test)

    Measured: 6 months

  2. biochemically validated abstinence (exhaled CO test & saliva cotinine test)

    Measured: 12 months

  3. self-efficacy in quitting

    Measured: 6 months

  4. self-efficacy in quitting

    Measured: 12 months

  5. number of quit attempts made

    Measured: 6 months

  6. number of quit attempts made

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2016 (estimated)
  2. Study startJun 2014
  3. Primary completionMay 2016
  4. Study completionNov 2016

Resources

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
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02701686
Sponsor's protocol ID
GOPC
Status last verified
Apr 2017
First submitted
26 Feb 2016
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing quit immediately (QI) and cut down to quit (CDTQ) in people with Smoking, run by The University of Hong Kong at 1 site in Hong Kong.

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 2 inclusion and 3 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 28 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 Hong Kong. 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?

self-reported 7-day point prevalence of abstinence (time frame: 6 months). The study lists 4 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 28 Apr 2017.

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