Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients

Beijing Normal University

Status: Active, not recruiting

Conditions: Smoking Cessation

Treatments: Behavioral: Initial phase: Personalized Chat Support (PCS); Behavioral: Self-help booklet; Behavioral: health warning leaflet; Behavioral: Second phase: Personalized Chat Support (PCS); Behavioral: Initial phase: Group Chat Support (GCS); Behavioral: Second phase: Multi-component Optional Support (MOS); Behavioral: 5A's / 5R's advice

Study type: Interventional

Funder types: Other

Identifiers

NCT06187142

mCessation in Chronic Patients

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3)

Experimental group

Description:

Personalized Chat Support (PCS) + Multi-component Optional Support (MOS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet

Treatment:

Behavioral: 5A's / 5R's advice

Behavioral: Second phase: Multi-component Optional Support (MOS)

Behavioral: health warning leaflet

Behavioral: Self-help booklet

Behavioral: Initial phase: Personalized Chat Support (PCS)

Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3)

Experimental group

Description:

Group Chat Support (GCS) + Personalized Chat Support (PCS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet

Treatment:

Behavioral: 5A's / 5R's advice

Behavioral: Initial phase: Group Chat Support (GCS)

Behavioral: Second phase: Personalized Chat Support (PCS)

Behavioral: health warning leaflet

Behavioral: Self-help booklet