NCT04399967

Brief Summary

The present study will examine (1) the effectiveness of a combined brief advice and personalized chat-based support on COVID-19 related smoking messages and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

June 13, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 19, 2020

Last Update Submit

May 22, 2023

Conditions

Smoking Cessation

Keywords

Smoking cessationQuit to WinCOVID-19

Outcome Measures

Primary Outcomes (2)

  • Biochemical validated quit rate

    The primary outcomes are biochemically validated quit rates (exhaled CO \< 4 ppm or salivary cotinine \< 30 ng/ml) at 3-month in the two groups

    3-month follow-up

  • Biochemical validated quit rate

    The primary outcomes are biochemically validated quit rates (exhaled CO \< 4 ppm or salivary cotinine \< 30 ng/ml) at 6-month in the two groups

    6-month follow-up

Secondary Outcomes (5)

  • Smoking quit rate change from baseline at 3-month follow-up

    3-month follow-up

  • Smoking quit rate change from baseline at 6-month follow-up

    6-month follow-up

  • Smoking reduction rate change from baseline at 3-month follow-up

    3-month follow-up

  • Smoking reduction rate change from baseline at 6-month follow-up

    6-month follow-up

  • Engagement in chat-based/text-based support

    3 and 6 months follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Chat-based support+ COVID-19 specific advice + AWARD advice + COVID-related health warning leaflet + referral card + COSH booklet

Behavioral: Chat-based supportBehavioral: AWARD plus COVID-specific adviceBehavioral: COVID-19 related health warning leafletBehavioral: Referral cardBehavioral: COSH Self-help smoking cessation booklet

Control Group

EXPERIMENTAL

Text-based support + AWARD advice + warning leaflet + referral card + COSH booklet

Behavioral: AWARD adviceBehavioral: Health warning leafletBehavioral: SMS-based supportBehavioral: Referral cardBehavioral: COSH Self-help smoking cessation booklet

Interventions

Chat-based supportBEHAVIORAL

Participants will receive three months of chat-based support through IM apps (e.g. WhatsApp, WeChat). The regular messages and instant messaging on psychosocial support aim to provide hygienic advice to reduce the risk of exposure to SARS-cov2, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.

Intervention Group
AWARD plus COVID-specific adviceBEHAVIORAL

Ask about smoking history, Warn about the risks associated with the COVID-19 and smoking (with a COVID-related health warning leaflet), Advise to quit as soon as possible during the COVID-19 pandemic, Refer smokers to SC services (with a referral card, see below for information), and Do it again: to repeat the intervention

Also known as: Ask, Warn, Advise, Refer, Do-it-again
Intervention Group
AWARD adviceBEHAVIORAL

Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).

Also known as: Ask, Warn, Advise, Refer, Do-it-again
Control Group
COVID-19 related health warning leafletBEHAVIORAL

The 2-sided color printed A4 leaflet, which covers the risk of COVID-19 and smoking and the most important messages to motivate smoking cessation

Intervention Group
Health warning leafletBEHAVIORAL

The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation.

Also known as: Brief leaflet on health warning and smoking cessation
Control Group
SMS-based supportBEHAVIORAL

Participants will receive regular SMS with similar frequency to Intervention group but with generic information on smoking cessation.

Control Group
Referral cardBEHAVIORAL

The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans.

Also known as: Smoking Cessation Service Card
Control GroupIntervention Group
COSH Self-help smoking cessation bookletBEHAVIORAL

A general smoking cessation self-help booklet

Control GroupIntervention Group

Eligibility Criteria

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

You may qualify if:

  • Hong Kong residents aged 18 or above
  • Smoke at least 1 tobacco stick per day or use e-cigarette daily in the past 3-month
  • Able to communicate in Cantonese (including reading Chinese)
  • Saliva cotinine 30 ng/ml or above
  • Intent to quit / reduce smoking
  • Able to use instant messaging tool (e.g., WhatsApp, WeChat) for communication.

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)

Hong Kong Council on Smoking and Health (COSH)

Hong Kong, Hong Kong, 852, China

Location

Related Publications (1)

  • Weng X, Luk TT, Wu YS, Zhao SZ, Cheung DYT, Tong HSC, Lai VWY, Lam TH, Wang MP. Effect of smoking-related COVID-19 risk messaging on smoking cessation in community smokers: A pragmatic randomized controlled trial. Tob Induc Dis. 2023 Jun 14;21:77. doi: 10.18332/tid/163176. eCollection 2023.

    PMID: 37323509DERIVED

MeSH Terms

Conditions

Smoking CessationCOVID-19

Interventions

corticosteroid hormone-induced factorReferral and Consultation

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Man Ping Kelvin Wang, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 22, 2020

Study Start

June 13, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2022

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)