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Trial record 60 of 2035 for:    Smoking Cessation

Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation

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ClinicalTrials.gov Identifier: NCT03800719
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Wang Man-Ping, The University of Hong Kong

Brief Summary:
This study aims to assess the effect of personalized support using instant messaging application on smoking cessation in smokers proactively recruited from smoking hotspots in Hong Kong.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: AWARD advice Behavioral: Health warning leaflet Behavioral: Active referral to smoking cessation (SC) services Behavioral: Regular messages through Instant Messaging (IM) Behavioral: Psychosocial support and referral to SC services through IM Behavioral: SMS message on general health Not Applicable

Detailed Description:

Detailed Description: With the advancement of information communication technologies (ICTs), instant messaging applications (IM Apps, e.g. WhatsApp and WeChat) can be used for providing synchronous, personalized, interactive interventions for health promotion. This study proposes to apply IM Apps for enhancing our tested brief smoking cessation (SC) intervention model from AWARD to e-AWARD (AWARD: Ask, Warn, Advise, Refer, Do-it-again,) without medications to increase SC in smokers proactively recruited in smoking hotspots in Hong Kong. Such smokers are the majority and have low quit rate. IM Apps allows trained SC advisors to proactively deliver personalized SC advices, response to smokers' needs promptly, and provide psychosocial support. No similar trials are found in PubMed, Cochrane Library and trial registries (ClinicalTrials.gov & ISRCTN) (except the pilot trial of this study). The aims of this study are as follows:

  1. To assess the main effect of the personalized support using instant messaging applications (Intervention) vs. Control group on biochemical validated smoking abstinence at 6-month and 12-month.
  2. To assess the effects on self-reported past 7-day abstinence, 24-week continuous abstinence, smoking reduction, self-efficacy of quitting, intention to quit, quit attempts and SC medications and services use at 6-month and 12-month.
  3. To identify the mediators, which can inform mechanisms of the intervention on SC.
  4. To evaluate the cost-effectiveness of the above interventions.
  5. To understand the effects subjects' experience of IM support on SC using a qualitative study approach.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 696 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation in Smokers Proactively Recruited From Smoking Hotspots in Hong Kong: a Pragmatic Randomized Controlled Trial
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, regular messages through Instant Messaging (IM), psychosocial support and referral to SC services through IM
Behavioral: AWARD advice

At baseline, brief smoking cessation advice following AWARD model will be delivered to subjects within about 2 to 5 minutes:

  • Ask about smoking history and habit
  • Warn about the risks of smoking using a leaflet
  • Advise to quit smoking as soon as possible and use NRT or SC services
  • Refer subjects to free smoking cessation services in Hong Kong if they agree
  • Do it again: smokers who have tried to quit but relapsed will be encouraged to quit again and those who have reduced smoking will be advised to further reduce or quit smoking

Behavioral: Health warning leaflet
At baseline, an A5-sized leaflet will be given to subjects, which includes information about risks of smoking, pictures of smoking-related diseases, and smoking cessation services provided in Hong Kong.

Behavioral: Active referral to smoking cessation (SC) services
At baseline, subjects will be encouraged to seek smoking cessation services in Hong Kong. If subjects agree, their contact information will be sent to the preferred service providers for a quick appointment and follow-up.

Behavioral: Regular messages through Instant Messaging (IM)
A total of pre-set 26 messages will be sent to subjects through WhatsApp 12 weeks after baseline to remind the quit date and to encourage abstinence. Messages are tailored based on subjects' sociodemographic characteristics and smoking habit following Social Cognitive Theory and Transtheoretical Model. Messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. The schedule will be adjusted according to the quit date and also smokers' requests. The format of regular messages will mainly be text-based but also include pictures, animations and videos.

Behavioral: Psychosocial support and referral to SC services through IM
Personalized interactive text or voice conversation will be provided by trained smoking cessation advisors through WhatsApp for 3 months after baseline. Advisors will periodically proactively send messages to subjects to initiate the conversation (e.g. asking recent progress of smoking cessation) and deliver evidence-based advice. Advisors will also actively refer subjects, if they have expressed the need, to smoking cessation services providers. A standard operation algorithm for advisors used in the pilot feasibility trial will be modified for the use.

Active Comparator: Control Group
AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, SMS message on general health
Behavioral: AWARD advice

At baseline, brief smoking cessation advice following AWARD model will be delivered to subjects within about 2 to 5 minutes:

  • Ask about smoking history and habit
  • Warn about the risks of smoking using a leaflet
  • Advise to quit smoking as soon as possible and use NRT or SC services
  • Refer subjects to free smoking cessation services in Hong Kong if they agree
  • Do it again: smokers who have tried to quit but relapsed will be encouraged to quit again and those who have reduced smoking will be advised to further reduce or quit smoking

Behavioral: Health warning leaflet
At baseline, an A5-sized leaflet will be given to subjects, which includes information about risks of smoking, pictures of smoking-related diseases, and smoking cessation services provided in Hong Kong.

Behavioral: Active referral to smoking cessation (SC) services
At baseline, subjects will be encouraged to seek smoking cessation services in Hong Kong. If subjects agree, their contact information will be sent to the preferred service providers for a quick appointment and follow-up.

Behavioral: SMS message on general health
After baseline, regular messages using SMS will be sent to subjects with similar frequency to Intervention group. The messages include information on general health and reminders on follow-up surveys and biochemical validation for quitting.




Primary Outcome Measures :
  1. Biochemically-validated abstinence at 6-month [ Time Frame: 6-month after baseline ]
    Defined as exhaled carbon monoxide <4ppm and saliva cotinine ≤ 10ng/ml

  2. Biochemically-validated abstinence at 12-month [ Time Frame: 12-month after baseline ]
    Defined as exhaled carbon monoxide <4ppm and saliva cotinine ≤ 10ng/ml


Secondary Outcome Measures :
  1. Self-reported past 7-day abstinence [ Time Frame: 6-month and 12-month after baseline ]
    Self-reported no cigarette smoking (even a single puff) in the past 7 days

  2. Self-reported 24-week continuous abstinence [ Time Frame: 6-month and 12-month after baseline ]
    Self-reported no cigarette smoking (even a single puff) in the past 24 weeks

  3. Smoking reduction [ Time Frame: 6-month and 12-month after baseline ]
    Self-reported reduction in the number of cigarettes smoked daily by at least 50% of the baseline amount

  4. Self-efficacy of quitting [ Time Frame: 6-month and 12-month after baseline ]
    Perceived importance, confidence and difficulties of quitting measured on a scale of 0-10 and a higher score indicates stronger perception

  5. Intention to quit [ Time Frame: 6-month and 12-month after baseline ]
    Any intention to quit smoking (yes/no) from baseline

  6. Quit attempts [ Time Frame: 6-month and 12-month after baseline ]
    Number of quit attempts from baseline

  7. Smoking cessation medication use [ Time Frame: 6-month and 12-month after baseline ]
    Any use of nicotine replacement therapy from baseline

  8. Smocking cessation services use [ Time Frame: 6-month and 12-month after baseline ]
    Any use of counselling, hotline, SC clinics and other SC services from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult smokers aged 18+ who smoke cigarette(s) daily.
  • Exhaled carbon monoxide (CO) level of 4ppm or above.
  • Having smartphones with IM Apps (WhatsApp) and have experience in using.
  • Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).

Exclusion Criteria:

  • Smokers who have psychiatric/psychological diseases or are on regular psychotropic medications.
  • Smokers who are using SC medication, NRT, other SC services or projects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800719


Contacts
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Contact: Fleur Lee, MPhil +852-39176955 fleurlee@hku.hk

Locations
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Hong Kong
School of Nursing, The University of Hong Kong Recruiting
Hong Kong, Hong Kong, 000000
Contact: Fleur Lee, MPhil    +852-39176955    fleurlee@hku.hk   
Sponsors and Collaborators
The University of Hong Kong

Publications:
Census and Statistics Department. Thematic Household Survey, Report No.59: Pattern of Smoking Hong Kong SAR: Hong Kong SAR Government. 2016. Available from: http://www.statistics.gov.hk/pub/B11302592016XXXXB0100.pdf.
Wright J. Very brief advice can be effective in encouraging smokers to quit 2013 Available from: http://www.guidelinesinpractice.co.uk/jan_13_wright_smoking_jan13#.Vf927RGqqko.
Thematic household survey Report No.62: Information technology usage and penetration. Hong Kong SAR Government. 2016. Available from: http://www.digital21.gov.hk/eng/statistics/download/informationsociety2013.pdf. 25. Bandura A.
Social Foundation of Thought and Action: A Social Cognitive Theory. Englewood Cliffs, NJ: Prentice-Hall; 1986.
Department of Health. Smoking Cessation Information Kit. Hong Kong SAR: 2015. Avialabe from: https://www.tco.gov.hk/english/quitting/files/kit09_eng.pdf
Petty RE, Cacioppo JT. The elaboration likelihood model of persuasion. Adv Exp Soc Psychol. 1986;19:124-92.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101.
Sabaté E. Adherence to long-term therapies: evidence for action. World Health Organization. 2003. Available from: http://apps.who.int/iris/bitstream/10665/42682/1/9241545992.pdf

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Responsible Party: Dr. Wang Man-Ping, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03800719     History of Changes
Other Study ID Numbers: GRF-IM
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Wang Man-Ping, The University of Hong Kong:
smoking cessation
active referral
IM