Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients
- Conditions
- Smoking Cessation
- Interventions
- Behavioral: 5A's / 5R's adviceBehavioral: health warning leafletBehavioral: Self-help booklet
- Registration Number
- NCT06187142
- Lead Sponsor
- Beijing Normal University
- Brief Summary
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.
- Detailed Description
Noncommunicable diseases (NCDs) , also known as chronic diseases, affect of a large of number of people and cause 41 million death each year, equivalent to 74% of globally mortality. In China, NCDs have caused 86% of deaths in the past three decades.
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- aged 18 or above, reside in Zhuhai for next 6 months;
- smoke at least 1 cigarette or use e-cigarettes daily;
- having a smartphone and a WeChat account, being able to use WeChat skillfully;
- having a diagnosis of at least one chronic disease related to smoking;
- intent to quit / reduce smoking.
- smokers who have communication barrier (either physically or cognitively)
- having participation in other smoking cessation programmes or services
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) health warning leaflet Personalized Chat Support (PCS) + Multi-component Optional Support (MOS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) Self-help booklet Personalized Chat Support (PCS) + Multi-component Optional Support (MOS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3) 5A's / 5R's advice Group Chat Support (GCS) + Personalized Chat Support (PCS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3) Self-help booklet Group Chat Support (GCS) + Personalized Chat Support (PCS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) 5A's / 5R's advice Personalized Chat Support (PCS) + Multi-component Optional Support (MOS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3) health warning leaflet Group Chat Support (GCS) + Personalized Chat Support (PCS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet
- Primary Outcome Measures
Name Time Method Participation rate of eligible smokers (Feasibility) Baseline The percentage of eligible smokers who agree to participate in the intervention
- Secondary Outcome Measures
Name Time Method Validated and self-reported abstinence of GCS-3 vs. GCS-2 3- and 6-month follow-up GCS-3 (add PCS) vs. GCS-2 (participants who are still smoking with 1-month) on validated abstinence (salivary cotinine \< 10 ng/ml) and self-reported abstinence.
Engagement in PCS / GCS intervention 3- and 6-months follow-up Self-reported engagement in PCS / GCS intervention in the different groups.
Validated and self-reported abstinence of PCS-3 vs. GCS-2 3- and 6-month follow-up PCS-3 (add MOS) vs. GCS-2 (participants who are still smoking with 1-month) on validated abstinence (salivary cotinine \< 10 ng/ml) and self-reported abstinence.
Validated and self-reported abstinence of PCS-3 vs. PCS-2 3- and 6-month follow-up PCS-3 (add MOS) vs. PCS-2 (participants who are still smoking with 1-month) on validated abstinence (salivary cotinine \< 10 ng/ml) and self-reported abstinence.
Smoking reduction rate 3- and 6-months follow-up Rate of smoking reduction by at least half of baseline amount in different groups.
Validated and self-reported abstinence of PCS vs. GCS 3- and 6-month follow-up PCS (subgroup 1+2+3) vs. GCS(subgroup 1+2+3) on validated abstinence (salivary cotinine \< 10 ng/ml) and self-reported abstinence.
Validated and self-reported abstinence of PCS-1+2 vs. GCS-1+2 3- and 6-month follow-up PCS-1+2 vs. GCS-1+2 on validated abstinence (salivary cotinine \< 10 ng/ml) and self-reported abstinence.
Validated abstinence and self-reported of PCS-3 vs. GCS-3 3- and 6-months follow-up Among non-responders to the initial treatments (PCS vs. GCS), compare the two augments treatments: MOS and PCS.
Trial Locations
- Locations (1)
Beijing Normal University
🇨🇳Zhuhai, Guangdong, China