- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03574077
Semi-personalized IM Smoking Cessation Interventions
January 8, 2019 updated by: Dr. Wang Man-Ping, The University of Hong Kong
Semi-personalized Smoking Cessation Interventions for Adult Smokers Recruited at Smoking Hotspots: a Pilot Randomized Controlled Trial
Text messaging can provide smokers with quitting methods, information on available smoking cessation (SC) services and social support.
This kind of intervention was proven to be effective for smoking cessation.
Instant messaging (IM), by sending text and pictures, could provide users with better instantaneous and inexpensive support in their time of need.
However, IM intervention is understudied in smoking cessation or other health-related areas to our knowledge, its approaches and efficacy warrant further investigation.
This study aims to assess the effect of the combined intervention (nicotine replacement therapy sampling, active referral, and brief advice plus a supportive semi-personalized instant messaging advice) on smoking cessation and to assess the effect of the above interventions on secondary outcomes, including quit intention and attempts, smoking reduction, level of nicotine dependence, use of nicotine replacement therapy (NRT) and SC services.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong, 000000
- School of Nursing, The University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 years or above and smoked at least 1 cigarette daily;
- Hong Kong residents able to read and speak Cantonese;
- Exhaled carbon monoxide of 4 ppm or above, assessed by a Smokerlyzer;
- Using a cell phone with instant messaging tool (e.g. WhatsApp, WeChat);
- Able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication;
Exclusion Criteria:
- Have psychiatric/ psychological diseases or regular psychotropic medications; and
- Using SC medication, NRT, other SC services or projects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Instant messaging
AWARD advice + NRT sampling + Active referral + Instant Messaging (IM)
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Tailored automatic, fix- scheduled regular messages will be sent and counselors will interact with smokers in the intervention group through WhatsApp since initial contact and until 2-month after baseline.
The interaction will follow the principle of Motivational Interviewing, which will focus on enabling change through the enhancement of intrinsic motivation and the exploration and resolution of ambivalence.
Counsellors will identify discrepancies between participants' thought and their action, support their autonomy, be empathetic towards the participant, avoid confrontation, and adjust to resistance.
Any smokers who do not use IM or refuse to receive IM messages will be contacted via SMS messages or telephone calls.
For smokers who do not respond to regular messages, 3 additional prompt messages will be sent in the 1st month to initiate a conversation.
AWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit or reduce smoking as soon as possible, Refer smokers to smoking cessation services (with a SC service information card), and Do it again: to repeat the intervention; participants who fail to quit or relapse will be encouraged to quit again (and those who have quit smoking will be encouraged to prevent relapse) during telephone follow-ups.
The whole process of AWARD can be delivered within 1 to 2 minutes.
One-week free nicotine replacement therapy (NRT) sampling (gum or patch) will be disseminated to participants who are interested to try after completing the baseline questionnaire.
An NRT use card containing reminders of NRT use and potential side effects will be given.
Counselors and research staff will also check the side effects of NRT use during WhatsApp interaction and telephone follow-ups.
SC ambassadors will introduce various SC services in Hong Kong (using the SC service information card) and motivate smokers to use the SC services.
Written consents will be obtained from smokers who are ready to book the service onsite for transfer of their contact telephone numbers to their chosen service providers.
Our research staff will transfer the information to the service providers within a week since the enrollment.
For smokers in Group A, our research staff will also assist them to re-book the appointments upon their request at follow-up.
SC ambassadors will encourage smokers in Group A who are not ready to book SC service to make an early appointment and assist them at follow-up.
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ACTIVE_COMPARATOR: SMS messaging
AWARD advice + NRT sampling + Active referral + SMS messaging
|
AWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit or reduce smoking as soon as possible, Refer smokers to smoking cessation services (with a SC service information card), and Do it again: to repeat the intervention; participants who fail to quit or relapse will be encouraged to quit again (and those who have quit smoking will be encouraged to prevent relapse) during telephone follow-ups.
The whole process of AWARD can be delivered within 1 to 2 minutes.
One-week free nicotine replacement therapy (NRT) sampling (gum or patch) will be disseminated to participants who are interested to try after completing the baseline questionnaire.
An NRT use card containing reminders of NRT use and potential side effects will be given.
Counselors and research staff will also check the side effects of NRT use during WhatsApp interaction and telephone follow-ups.
SC ambassadors will introduce various SC services in Hong Kong (using the SC service information card) and motivate smokers to use the SC services.
Written consents will be obtained from smokers who are ready to book the service onsite for transfer of their contact telephone numbers to their chosen service providers.
Our research staff will transfer the information to the service providers within a week since the enrollment.
For smokers in Group A, our research staff will also assist them to re-book the appointments upon their request at follow-up.
SC ambassadors will encourage smokers in Group A who are not ready to book SC service to make an early appointment and assist them at follow-up.
All smokers will receive fix-schedule general messages on SC through short message service (SMS) since their initial participation until 2-month after baseline.
These messages include: (a) brief health warning, (b) benefit of quitting, (c) methods to quit and to cope with craving, and (d) SC services and their effectiveness.
General SC messages will be sent twice per week in the 1st month and once per week in the 2nd month after joining this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Biochemically validated abstinence
Time Frame: 3-month follow-up
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Biochemically validated abstinence (exhaled carbon monoxide <4 ppm and saliva cotinine <= 10 ng/ml)
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3-month follow-up
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Biochemically validated abstinence
Time Frame: 6-month follow-up
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Biochemically validated abstinence (exhaled carbon monoxide <4 ppm and saliva cotinine <= 10 ng/ml)
|
6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported 7-day point prevalence abstinence
Time Frame: 3-month and 6-month follow-up
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Self-reported no cigarette smoking (even a single puff) in the past 7 days
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3-month and 6-month follow-up
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Level of nicotine dependence
Time Frame: 3-month and 6-month follow-up
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The Heaviness of Smoking Index, a validated scale, will be used to measure the level of nicotine dependence.
This scale consists of 2 questions: (1) how soon after waking up does a participant smoke the first cigarette with responses "within 5 minutes", "6-30 minutes", "31-60 minutes" and "after 60 minutes"; (2) how many cigarettes does a participant smoke in a day with responses "1-10", "11-20" "21-30" and ">30".
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3-month and 6-month follow-up
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Readiness to quit smoking
Time Frame: 3-month and 6-month follow-up
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Readiness to quit smoking will be measured by a question asking the planned quit day based on the Transtheoretical Model with the following responses: within 7days, with 30 days, within 60 days, not yet decided.
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3-month and 6-month follow-up
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Quit attempts
Time Frame: 3-month and 6-month follow-up
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Self-reported quit attempts after enrollment in the study
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3-month and 6-month follow-up
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Smoking reduction
Time Frame: 3-month and 6-month follow-up
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Reduction in the number of cigarettes smoked daily by at least 50% of the baseline amount
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3-month and 6-month follow-up
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NRT use
Time Frame: 3-month and 6-month follow-up
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The amount of nicotine replacement therapy (NRT) used including the sampling received at baseline, NRT received from SC services, NRT bought by participants
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3-month and 6-month follow-up
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SC services used
Time Frame: 3-month and 6-month follow-up
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Smoking cessation service used after enrollment in the study
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3-month and 6-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 27, 2017
Primary Completion (ACTUAL)
October 31, 2018
Study Completion (ACTUAL)
October 31, 2018
Study Registration Dates
First Submitted
November 9, 2017
First Submitted That Met QC Criteria
June 27, 2018
First Posted (ACTUAL)
June 29, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 8, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- UW15-232
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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