NCT05777005

Brief Summary

This study aims to explore the feasibility, preliminary effectiveness, and implementation outcomes of chatbot-led smoking cessation support in community smokers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 20, 2024

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

March 8, 2023

Last Update Submit

August 16, 2024

Conditions

Smoking CessationMobile Health

Outcome Measures

Primary Outcomes (2)

  • Participation rate of eligible smokers

    the percentage of eligible smokers out of the total number of smokers screened

    Baseline

  • Biochemical validated quit rate at 6 months follow-up

    The primary outcomes are biochemically validated quit rate (exhaled CO \< 4 ppm or salivary cotinine \< 30 ng/ml)

    6 months follow-up

Secondary Outcomes (4)

  • Biochemical validated quit rate at 3 months follow-up

    3 months follow-up

  • Self-reported 7-day point prevalence quit rate

    3 and 6 months follow-up

  • Smoking reduction rate

    3 and 6 months follow-up

  • Engagement in chatbot-led group support and/or counselor-led individual support

    3 and 6 months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

5A's/5R's advice+ Chatbot-led group support+ Counselor-led individual support+ health warning leaflet+ Self-help booklet

Behavioral: 5A's/5R's adviceOther: Brief leaflet on health warning and smoking cessationOther: Self-help smoking cessation bookletBehavioral: Counselor-led individual supportBehavioral: Chatbot-led group support

Control group

ACTIVE COMPARATOR

5A's/5R's advice+ Chatbot-led group support+ health warning leaflet+ Self-help booklet

Behavioral: 5A's/5R's adviceOther: Brief leaflet on health warning and smoking cessationOther: Self-help smoking cessation bookletBehavioral: Chatbot-led group support

Interventions

5A's/5R's adviceBEHAVIORAL

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 groupIntervention group
Brief leaflet on health warning and smoking cessationOTHER

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 groupIntervention group
Self-help smoking cessation bookletOTHER

The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.

Control groupIntervention group
Counselor-led individual supportBEHAVIORAL

Participants will receive three months of counselor-led individual support via WeChat. The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.

Intervention group
Chatbot-led group supportBEHAVIORAL

Participants will receive three months of chatbot-led group support via WeChat.

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 and above, reside in Zhuhai for the 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.

You may not qualify if:

  • Smokers who have communication barrier (either physically or cognitively);
  • Smokers who are currently participating in other SC programmes or services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Normal University

Zhuhai, Guangdong, 519087, China

RECRUITING

Related Publications (1)

  • Weng X, Yin H, Liu K, Song C, Xie J, Guo N, Wang MP. Chatbot-Led Support Combined With Counselor-Led Support on Smoking Cessation in China: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 23;13:e58636. doi: 10.2196/58636.

    PMID: 39312291DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Xue Weng

CONTACT

3621259xueweng@bnu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 20, 2023

Study Start

March 6, 2023

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

August 20, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)