Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients

NCT06187142 | Unknown DMC

• 1 other identifier: mCessation in Chronic Patients
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Smoking cessation; Chronic patients; SMART design

Outcome Measures

Primary Outcomes (1)

• Participation rate of eligible smokers (Feasibility)

  The percentage of eligible smokers who agree to participate in the intervention

  Baseline

Secondary Outcomes (8)

• Validated and self-reported abstinence of PCS vs. GCS

  3- and 6-month follow-up

• Validated and self-reported abstinence of PCS-3 vs. GCS-2

  3- and 6-month follow-up

• Validated and self-reported abstinence of PCS-3 vs. PCS-2

  3- and 6-month follow-up

• Validated and self-reported abstinence of GCS-3 vs. GCS-2

  3- and 6-month follow-up

• Validated and self-reported abstinence of PCS-1+2 vs. GCS-1+2

  3- and 6-month follow-up

Study Arms (2)

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

EXPERIMENTAL

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); Behavioral: Second phase: Multi-component Optional Support (MOS); Behavioral: 5A's / 5R's advice; Behavioral: health warning leaflet; Behavioral: Self-help booklet

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

EXPERIMENTAL

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

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

Interventions

Initial phase: Personalized Chat Support (PCS) BEHAVIORAL

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).

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

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

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.

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

Initial phase: Group Chat Support (GCS) BEHAVIORAL

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).

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

Second phase: Personalized Chat Support (PCS) BEHAVIORAL

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.

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

5A's / 5R's advice BEHAVIORAL

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.

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

health warning leaflet BEHAVIORAL

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.

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

Self-help booklet BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Normal University: lead

Study Sites (1)

Beijing Normal University

Zhuhai, Guangdong, 519087, China

Location

Related Publications (1)

• 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.

  PMID: 39324617 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2024
• Primary Completion: July 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)