Clinical trial NCT06187142: Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients
Official title: Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients: a Sequential, Multiple Assignment, Randomized Trial (SMART)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Chronic patients
SMART design
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

1. aged 18 or above, reside in Zhuhai for next 6 months;
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:

1. smokers who have communication barrier (either physically or cognitively)
2. having participation in other smoking cessation programmes or services

Primary outcomes:
measure: Participation rate of eligible smokers (Feasibility)
timeFrame: Baseline
Secondary outcomes:
measure: Validated and self-reported abstinence of PCS vs. GCS
timeFrame: 3- and 6-month follow-up
measure: Validated and self-reported abstinence of PCS-3 vs. GCS-2
timeFrame: 3- and 6-month follow-up
measure: Validated and self-reported abstinence of PCS-3 vs. PCS-2
timeFrame: 3- and 6-month follow-up
measure: Validated and self-reported abstinence of GCS-3 vs. GCS-2
timeFrame: 3- and 6-month follow-up
measure: Validated and self-reported abstinence of PCS-1+2 vs. GCS-1+2
timeFrame: 3- and 6-month follow-up
measure: Smoking reduction rate
timeFrame: 3- and 6-months follow-up
measure: Engagement in PCS / GCS intervention
timeFrame: 3- and 6-months follow-up
measure: Validated abstinence and self-reported of PCS-3 vs. GCS-3
timeFrame: 3- and 6-months follow-up
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Beijing Normal University
state: Guangdong
Study officials:
References: