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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • School of Nursing, The University of Hong Kong

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18 years or above and smoked at least 1 cigarette daily;
  2. Hong Kong residents able to read and speak Cantonese;
  3. Exhaled carbon monoxide of 4 ppm or above, assessed by a Smokerlyzer;
  4. Using a cell phone with instant messaging tool (e.g. WhatsApp, WeChat);
  5. Able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication;

Exclusion Criteria:

  1. Have psychiatric/ psychological diseases or regular psychotropic medications; and
  2. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Instant messaging
AWARD advice + NRT sampling + Active referral + Instant Messaging (IM)
Behavioral: Instant Messaging (IM)
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.
Behavioral: AWARD advice
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.
Behavioral: NRT sampling
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.
Behavioral: Active referral
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.
ACTIVE_COMPARATOR: SMS messaging
AWARD advice + NRT sampling + Active referral + SMS messaging
Behavioral: AWARD advice
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.
Behavioral: NRT sampling
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.
Behavioral: Active referral
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.
Behavioral: SMS messaging
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biochemically validated abstinence
Time Frame: 3-month follow-up
Biochemically validated abstinence (exhaled carbon monoxide <4 ppm and saliva cotinine <= 10 ng/ml)
3-month follow-up
Biochemically validated abstinence
Time Frame: 6-month follow-up
Biochemically validated abstinence (exhaled carbon monoxide <4 ppm and saliva cotinine <= 10 ng/ml)
6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported 7-day point prevalence abstinence
Time Frame: 3-month and 6-month follow-up
Self-reported no cigarette smoking (even a single puff) in the past 7 days
3-month and 6-month follow-up
Level of nicotine dependence
Time Frame: 3-month and 6-month follow-up
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".
3-month and 6-month follow-up
Readiness to quit smoking
Time Frame: 3-month and 6-month follow-up
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.
3-month and 6-month follow-up
Quit attempts
Time Frame: 3-month and 6-month follow-up
Self-reported quit attempts after enrollment in the study
3-month and 6-month follow-up
Smoking reduction
Time Frame: 3-month and 6-month follow-up
Reduction in the number of cigarettes smoked daily by at least 50% of the baseline amount
3-month and 6-month follow-up
NRT use
Time Frame: 3-month and 6-month follow-up
The amount of nicotine replacement therapy (NRT) used including the sampling received at baseline, NRT received from SC services, NRT bought by participants
3-month and 6-month follow-up
SC services used
Time Frame: 3-month and 6-month follow-up
Smoking cessation service used after enrollment in the study
3-month and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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