Mobile Chat Messaging for Smoking Relapse Prevention
Primary Purpose
Smoking Cessation
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Standard smoking cessation treatment
Personalised chat messaging
SMS text messaging
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring relapse prevention, recurrence, mHealth, instant messaging, WhatsApp, chatbot, conversational agent, Chinese
Eligibility Criteria
Inclusion Criteria:
- Hong Kong residents aged 18 years or above
- Own a smartphone with WhatsApp installed
- Enrolled in a smoking cessation program under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
- Smoked daily before the present quit attempt
- Abstained from smoking for 3 to 30 days
Exclusion Criteria:
- Diagnosed with a mental disease or on regular psychotropic drugs
- Participating in other ongoing smoking cessation studies
Sites / Locations
- Tung Wah Group of Hospitals Integrated Centre on Smoking CessationRecruiting
- United Christian Nethersole Community Health Service Smoking Cessation ProgrammeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile chat messaging
SMS messaging
Arm Description
Standard smoking cessation treatment + Personalised chat messaging
Standard smoking cessation treatment + Regular SMS text messaging generic information about the harms of smoking and the benefits of quitting
Outcomes
Primary Outcome Measures
Biochemically validated tobacco abstinence
Verified by an exhaled carbon monoxide level of lower than 5 parts per million or a negative salivary cotinine test
Secondary Outcome Measures
Self-reported 6-month prolonged tobacco abstinence
Not more than five lapses permitted for 6 months after baseline
Self-reported 7-day point prevalent tobacco abstinence
Being completely smoke-free in the past 7 days
Self-reported 7-day point prevalent tobacco abstinence
Being completely smoke-free in the past 7 days
Self-reported relapse rate
Defined as use of tobacco products for 7 consecutive days or longer
Self-reported relapse rate
Defined as use of tobacco products for 7 consecutive days or longer
Full Information
NCT ID
NCT05370352
First Posted
May 6, 2022
Last Updated
October 3, 2023
Sponsor
The University of Hong Kong
Collaborators
Health and Medical Research Fund, Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
1. Study Identification
Unique Protocol Identification Number
NCT05370352
Brief Title
Mobile Chat Messaging for Smoking Relapse Prevention
Official Title
Effectiveness of Mobile Chat Messaging for Preventing Relapse in Smokers Who Have Recently Quit Smoking: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Health and Medical Research Fund, Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Most smokers return to smoking (relapse) after making a quit attempt, but evidence of effective intervention to prevent relapse is scarce. Taking advantage of recent advances in mobile technologies, this study aims to evaluate the effectiveness of a mobile chat messaging-based relapse prevention intervention in promoting successful quitting in people who recently quit smoking (recent abstainers) using a randomised controlled trial design.
Detailed Description
Most smokers who made quit attempts and achieved short-term abstinence return to smoking (relapse) over time, even when aided by effective smoking cessation treatment. Since relapse mostly occurred in the first 4 weeks of abstinence, relapse prevention in the early phase of abstinence could potentially boost long-term abstinence. Several behavioural interventions for smoking relapse prevention have been proposed and tested in RCTs. Yet, a 2019 Cochrane review did not find traditional approaches, including self-help materials, telephone counselling and group therapy, effective in increasing long-term abstinence at 6 months or longer.
The widespread use of mobile devices has provided a highly accessible and scalable means for novel behavioural interventions for smoking cessation. A formative qualitative study in current smokers conducted by the investigators showed that mobile chat messaging is a feasible and acceptable platform for delivering smoking cessation support. A subsequent cluster randomised controlled trial on 1148 smokers found that mobile chat messaging combined with brief intervention was effective in increasing biochemically validated abstinence at 6 months. Nonetheless, whether mobile chat messaging could prevent relapse in recent abstainers has remained untested.
The investigators did a pilot trial to confirm the feasibility and acceptability of mobile chat messaging for relapse prevention in recent abstainers. This study aims to evaluate the effectiveness of mobile chat messaging relapse prevention intervention in promoting abstinence in recent abstainers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
relapse prevention, recurrence, mHealth, instant messaging, WhatsApp, chatbot, conversational agent, Chinese
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
586 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile chat messaging
Arm Type
Experimental
Arm Description
Standard smoking cessation treatment + Personalised chat messaging
Arm Title
SMS messaging
Arm Type
Active Comparator
Arm Description
Standard smoking cessation treatment + Regular SMS text messaging generic information about the harms of smoking and the benefits of quitting
Intervention Type
Behavioral
Intervention Name(s)
Standard smoking cessation treatment
Intervention Description
Standard smoking cessation treatment (behavioural and pharmacotherapy) provided by Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
Intervention Type
Behavioral
Intervention Name(s)
Personalised chat messaging
Intervention Description
Personalised chat messaging focusing on smoking relapse prevention for 3 months from randomisation. A trained counsellor will interact with a participant individually and provide relapse prevention advice via WhatsApp. The participant can also access a supportive chatbot in WhatsApp, which will provide on-demand smoking relapse prevention support when the counsellor is not available (e.g., during nighttime).
Intervention Type
Behavioral
Intervention Name(s)
SMS text messaging
Intervention Description
SMS text messaging on generic information about the harms of smoking and the benefits of quitting for 3 months from randomisation.
Primary Outcome Measure Information:
Title
Biochemically validated tobacco abstinence
Description
Verified by an exhaled carbon monoxide level of lower than 5 parts per million or a negative salivary cotinine test
Time Frame
6 months after randomisation
Secondary Outcome Measure Information:
Title
Self-reported 6-month prolonged tobacco abstinence
Description
Not more than five lapses permitted for 6 months after baseline
Time Frame
6 months after randomisation
Title
Self-reported 7-day point prevalent tobacco abstinence
Description
Being completely smoke-free in the past 7 days
Time Frame
3 months after randomisation
Title
Self-reported 7-day point prevalent tobacco abstinence
Description
Being completely smoke-free in the past 7 days
Time Frame
6 months after randomisation
Title
Self-reported relapse rate
Description
Defined as use of tobacco products for 7 consecutive days or longer
Time Frame
3 months after randomisation
Title
Self-reported relapse rate
Description
Defined as use of tobacco products for 7 consecutive days or longer
Time Frame
6 months after randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hong Kong residents aged 18 years or above
Own a smartphone with WhatsApp installed
Enrolled in a smoking cessation program under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
Smoked daily before the present quit attempt
Abstained from smoking for 3 to 30 days
Exclusion Criteria:
Diagnosed with a mental disease or on regular psychotropic drugs
Participating in other ongoing smoking cessation studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu Tsun Luk, PhD, RN
Phone
39177574
Email
lukkevin@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzu Tsun Luk, PhD, RN
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nga Ting Grace Wong
Phone
2332 8977
Facility Name
United Christian Nethersole Community Health Service Smoking Cessation Programme
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ka Hong John Lee, MMedSci
Phone
31569012
Email
john.lee@ucn.org.hk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Request to obtain IPD can be made to the principal invesitgator on reasonable request
Citations:
PubMed Identifier
30702431
Citation
Luk TT, Wong SW, Lee JJ, Chan SS, Lam TH, Wang MP. Exploring Community Smokers' Perspectives for Developing a Chat-Based Smoking Cessation Intervention Delivered Through Mobile Instant Messaging: Qualitative Study. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11954. doi: 10.2196/11954.
Results Reference
background
PubMed Identifier
30593882
Citation
Luk TT, Li WHC, Cheung DYT, Wong SW, Kwong ACS, Lai VWY, Chan SS, Lam TH, Wang MP. Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial. Contemp Clin Trials. 2019 Feb;77:70-75. doi: 10.1016/j.cct.2018.12.013. Epub 2018 Dec 26.
Results Reference
background
PubMed Identifier
33323188
Citation
Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31.
Results Reference
background
PubMed Identifier
35166327
Citation
Luk TT, Cheung YTD, Chan HC, Fok PW, Ho KS, Sze CD, Lam TH, Wang MP. Mobile Chat Messaging for Preventing Smoking Relapse Amid the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2023 Jan 5;25(2):291-297. doi: 10.1093/ntr/ntac045.
Results Reference
background
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Mobile Chat Messaging for Smoking Relapse Prevention
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