Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients
NCT ID: NCT06187142
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
130 participants
INTERVENTIONAL
2024-01-01
2024-12-15
Brief Summary
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Detailed Description
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Tobacco use is a type of modifiable behavioural risk factor for the development of noncommunicable disease and death. It not only increases the risk of developing NCDs, but also exacerbates their severity and complications. Tobacco causes over 8 million deaths annually. China has the world's largest population of smokers, more than 300 million. Tobacco related deaths in China are 1 million per year. Smoking cessation is one of the most effective and cost-efficient measures for the prevention and control of NCDs. It can reduce the morbidity and mortality rates of NCDs and improve the health and quality of life of patients.
Meanwhile, among current smokers in China, the prevalence of tobacco dependence was 49.7%, smoking cessation services are extremely limited in China, with only 366 clinics nationwide. For smokers with NCDs, hospitalization or outpatient treatment due to health problems can be a 'teachable moment' for quit smoking. Most physicians are unable to provide comprehensive cessation advice due to time and resource constraints, and chronic patients face many relapse triggers after leaving the hospital. Therefore, it is necessary to implement staged and personalized smoking cessation interventions for chronic patients.
To facilitate smoking cessation among chronic patients, we propose to use a sequential multiple assignment randomized trial (SMART) design. This adaptive approach is a concept of stepped treatment that aims to address the unmet needs of chronic patients and enhance smoking cessation outcomes.
The study aims to facilitate mobile phone-based cessation support for chronic patients using a sequential multiple assignment randomized trial (SMART) , and combines different effective treatments to enhance engagement and determine the most effective adaptive interventions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3)
Personalized Chat Support (PCS) + Multi-component Optional Support (MOS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet
Initial phase: Personalized Chat Support (PCS)
Participants will receive three months of personalized chat support through WeChat. A total of 24 pre-set messages will be sent with the schedule of 3 times a week for 2 weeks, twice a week for the next 8 weeks and once a week for the last 2 weeks. These messages cover generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and hazards of smoking for chronic diseases experienced by different participants. Counsellors will respond to the participants' messages instantly. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PCS (subgroup PCS-1). Incomplete responders (smokers) will be randomly assigned to continue PCS (subgroup PCS-2) or receive PCS and MOS (subgroup PCS-3).
Second phase: Multi-component Optional Support (MOS)
For incomplete responders (subgroup PCS-3) randomized to MOS, the available intervention options include phone counseling, family/peer support group and financial incentive for nicotine replacement therapy. Participants will be guided by cessation counsellors at 1-month follow-up to choose any combination of MOS based on their prefer choice or combination of MOS. If MOS participants cannot be followed up at 1-month, they will continue PCS by default.
5A's / 5R's advice
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
health warning leaflet
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
Self-help booklet
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3)
Group Chat Support (GCS) + Personalized Chat Support (PCS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet
Initial phase: Group Chat Support (GCS)
Participant will receive three months of group chat support through WeChat. In this group, participants can send 'No Smoking' and the smart quit-smoking assistant will record it. A smoking cessation clinic doctor in the group will respond to participants' questions about smoking cessation. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive GCS (subgroup GCS-1). Incomplete responders (smokers) will be randomly assigned to continue GCS (subgroup GCS-2) or receive GCS and PCS (subgroup GCS-3).
Second phase: Personalized Chat Support (PCS)
For incomplete responders (subgroup GCS-3) randomized to PCS, participants will receive the same intervention as Group PCS delivered at the initial stage. Participants will receive two months of personalized messages through WeChat. Please refer to Intervention Group 'Initial phase: Personalized Chat Support (PCS) for details.
5A's / 5R's advice
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
health warning leaflet
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
Self-help booklet
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
Interventions
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Initial phase: Personalized Chat Support (PCS)
Participants will receive three months of personalized chat support through WeChat. A total of 24 pre-set messages will be sent with the schedule of 3 times a week for 2 weeks, twice a week for the next 8 weeks and once a week for the last 2 weeks. These messages cover generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and hazards of smoking for chronic diseases experienced by different participants. Counsellors will respond to the participants' messages instantly. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PCS (subgroup PCS-1). Incomplete responders (smokers) will be randomly assigned to continue PCS (subgroup PCS-2) or receive PCS and MOS (subgroup PCS-3).
Second phase: Multi-component Optional Support (MOS)
For incomplete responders (subgroup PCS-3) randomized to MOS, the available intervention options include phone counseling, family/peer support group and financial incentive for nicotine replacement therapy. Participants will be guided by cessation counsellors at 1-month follow-up to choose any combination of MOS based on their prefer choice or combination of MOS. If MOS participants cannot be followed up at 1-month, they will continue PCS by default.
Initial phase: Group Chat Support (GCS)
Participant will receive three months of group chat support through WeChat. In this group, participants can send 'No Smoking' and the smart quit-smoking assistant will record it. A smoking cessation clinic doctor in the group will respond to participants' questions about smoking cessation. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive GCS (subgroup GCS-1). Incomplete responders (smokers) will be randomly assigned to continue GCS (subgroup GCS-2) or receive GCS and PCS (subgroup GCS-3).
Second phase: Personalized Chat Support (PCS)
For incomplete responders (subgroup GCS-3) randomized to PCS, participants will receive the same intervention as Group PCS delivered at the initial stage. Participants will receive two months of personalized messages through WeChat. Please refer to Intervention Group 'Initial phase: Personalized Chat Support (PCS) for details.
5A's / 5R's advice
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
health warning leaflet
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
Self-help booklet
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
Eligibility Criteria
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Inclusion Criteria
2. smoke at least 1 cigarette or use e-cigarettes daily;
3. having a smartphone and a WeChat account, being able to use WeChat skillfully;
4. having a diagnosis of at least one chronic disease related to smoking;
5. intent to quit / reduce smoking.
Exclusion Criteria
2. having participation in other smoking cessation programmes or services
18 Years
ALL
No
Sponsors
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Beijing Normal University
OTHER
Responsible Party
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Locations
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Beijing Normal University
Zhuhai, Guangdong, China
Countries
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References
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Weng X, Song C, Liu K, Zhao S, Yang H, Wang MP. Mobile Phone-Based Smoking-Cessation Intervention in Patients With Chronic Diseases in China: A Sequential Multiple Assignment Randomized Trial. Nicotine Tob Res. 2025 Feb 24;27(3):502-510. doi: 10.1093/ntr/ntae230.
Other Identifiers
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mCessation in Chronic Patients
Identifier Type: -
Identifier Source: org_study_id
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