Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients

Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients: a Sequential, Multiple Assignment, Randomized Trial (SMART)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Initial phase: Personalized Chat Support (PCS); Behavioral: Second phase: Multi-component Optional Support (MOS); Behavioral: 5A's / 5R's advice; Behavioral: health warning leaflet; Behavioral: Self-help booklet; Behavioral: Initial phase: Group Chat Support (GCS); Behavioral: Second phase: Personalized Chat Support (PCS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519087
      • Beijing Normal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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).; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: Self-help booklet; The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
Experimental: 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	Behavioral: 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.; Behavioral: 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.; Behavioral: Self-help booklet; The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.; Behavioral: 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).; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate of eligible smokers (Feasibility)	The percentage of eligible smokers who agree to participate in the intervention	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validated and self-reported abstinence of PCS vs. GCS	PCS (subgroup 1+2+3) vs. GCS(subgroup 1+2+3) on validated abstinence (salivary cotinine < 10 ng/ml) and self-reported abstinence.	3- and 6-month follow-up
Validated and self-reported abstinence of PCS-3 vs. GCS-2	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.	3- and 6-month follow-up
Validated and self-reported abstinence of PCS-3 vs. PCS-2	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.	3- and 6-month follow-up
Validated and self-reported abstinence of GCS-3 vs. GCS-2	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.	3- and 6-month follow-up
Validated and self-reported abstinence of PCS-1+2 vs. GCS-1+2	PCS-1+2 vs. GCS-1+2 on validated abstinence (salivary cotinine < 10 ng/ml) and self-reported abstinence.	3- and 6-month follow-up
Smoking reduction rate	Rate of smoking reduction by at least half of baseline amount in different groups.	3- and 6-months follow-up
Engagement in PCS / GCS intervention	Self-reported engagement in PCS / GCS intervention in the different groups.	3- and 6-months follow-up
Validated abstinence and self-reported of PCS-3 vs. GCS-3	Among non-responders to the initial treatments (PCS vs. GCS), compare the two augments treatments: MOS and PCS.	3- and 6-months follow-up

Collaborators and Investigators

• Sponsor: Beijing Normal University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): July 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Smoking cessation; SMART design; Chronic patients
• Other Study ID Numbers: mCessation in Chronic Patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No