NCT03992742

Brief Summary

The present study will examine (1) effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence using a sequential multiple assignment randomised trial (SMART) 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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

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

First Submitted

Initial submission to the registry

June 12, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 21, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

June 12, 2019

Last Update Submit

August 18, 2020

Conditions

Keywords

Smoking cessationQuit to WinCocktail interventionSMART design

Outcome Measures

Primary Outcomes (2)

  • Validated abstinence of PIM + OCI vs. RIM + PIM

    PIM + OCI (subgroup A+B+C) vs. RIM + PIM (subgroup D+E+F) on validated abstinence (exhaled CO \< 4 ppm and salivary cotinine \< 10 ng/ml)

    6-month follow-up

  • Validated abstinence of OCI vs. RIM in incomplete responders

    OCI (subgroup A) vs. RIM (subgroup E) in incomplete responders (those who are still smoking at 1-month) on validated abstinence (exhaled CO \< 4 ppm and salivary cotinine \< 10 ng/ml)

    6-month follow-up

Secondary Outcomes (11)

  • Validated abstinence of PIM + OCI vs. RIM + PIM adjusted for potential imbalance of baseline characteristic

    6-month follow-up

  • Validated abstinence of OCI vs. RIM in incomplete responders adjusted for potential imbalance of baseline characteristic

    6-month follow-up

  • Validated and self-reported abstinence of OCI vs. PIM in incomplete responders

    3- and 6-month follow-up

  • Validated and self-reported abstinence of PIM vs. RIM in incomplete responders

    3- and 6-month follow-up

  • Validated and self-reported abstinence of PIM vs. RIM

    3- and 6-month follow-up

  • +6 more secondary outcomes

Study Arms (2)

Intervention Group (subgroup A+B+C)

EXPERIMENTAL

Personalized instant messaging (PIM) + optional cocktail interventions (OCI) + AWARD advice + referral card + warning leaflet+ COSH booklet

Behavioral: Initial phase: personalized instant messaging (PIM)Behavioral: Second phase: optional cocktail interventions (OCI)Behavioral: AWARD adviceBehavioral: Warning leafletBehavioral: Referral cardBehavioral: COSH booklet

Control Group (subgroup D+E+F)

EXPERIMENTAL

Regular instant messaging (RIM) + personalized instant messaging (PIM) + AWARD advice + referral card + warning leaflet+ COSH booklet

Behavioral: Initial phase: regular instant messaging (RIM)Behavioral: Second phase: personalized instant messaging (PIM)Behavioral: AWARD adviceBehavioral: Warning leafletBehavioral: Referral cardBehavioral: COSH booklet

Interventions

intervention Group participants will receive three months of personalized interaction through IM Apps (e.g. WhatsApp, WeChat). Our counsellors will trigger the conversation and encourage the participants to set a quit day. A total of pre-set 26 messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. These messages covered generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and encouragement to quit and use SC services. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PIM (subgroup C). Incomplete responders (smokers) will be randomized to continue PIM (subgroup B) or receive OCI (subgroup A).

Intervention Group (subgroup A+B+C)

For incomplete respondents (subgroup A) randomized to OCI, the available intervention options include multi-media messages, active referral plus financial incentive, phone counseling, family/peer support and medications (NRT). Participants will be guided by cessation counsellors at 1-month follow-up telephone survey to choose any combination of OCI based on their preference. If OCI participants cannot be followed up at 1-month, they will receive multi-media messages by default.

Intervention Group (subgroup A+B+C)

Participants enrolled in the Control Group will receive regular messages via IM services (e.g. WhatsApp, WeChat) since initial contact and until 3-month after baseline with a tapering schedule: 1) Baseline to 4-week (1-month): 2 times/ week (8 in total); 2) 4-week to 12-week (2- \& 3-month): 1 time/week (8 in total). SC messages will generally include benefits of SC, encouragement on abstinence and use of SC services, tips on avoiding/ handling craving and reminder of participating in telephone follow-up. A reminder to participate in the telephone follow-up will also be sent at 1-, 2-, 3- and 6-month, making up a total of 20 messages. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive RIM (subgroup F). Incomplete responders (smokers) will be second randomized to continue RIM (subgroup E) or receive PIM (subgroup D). Those who are unable to follow up at 1-month will be considered as nonresponsive to the intervention.

Control Group (subgroup D+E+F)

For incomplete responders allocated to PIM (subgroup D), participants will receive the same intervention as the Group A delivered at the initial stage. Participants will receive two months of personalized interaction through IM application. Please refer to Intervention Group "Initial phase: personalized instant messaging (PIM)" for details.

Control Group (subgroup D+E+F)
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 (subgroup D+E+F)Intervention Group (subgroup A+B+C)
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 (subgroup D+E+F)Intervention Group (subgroup A+B+C)
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 Group (subgroup D+E+F)Intervention Group (subgroup A+B+C)
COSH bookletBEHAVIORAL

A general smoking cessation self-help booklet

Also known as: COSH self-help smoking cessation booklet
Control Group (subgroup D+E+F)Intervention Group (subgroup A+B+C)

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 cigarette per day in the past 3-month
  • Able to communicate in Cantonese (including reading Chinese)
  • Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO Smokerlyzer.
  • 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)
  • Have participation in other smoking cessation programmes or services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Zhao SZ, Weng X, Luk TT, Wu Y, Cheung DYT, Li WHC, Tong H, Lai V, Lam TH, Wang MP. Adaptive interventions to optimise the mobile phone-based smoking cessation support: study protocol for a sequential, multiple assignment, randomised trial (SMART). Trials. 2022 Aug 18;23(1):681. doi: 10.1186/s13063-022-06502-7.

MeSH Terms

Conditions

Smoking Cessation

Interventions

corticosteroid hormone-induced factorReferral and Consultation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Man Ping 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
Assistant Professor

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 20, 2019

Study Start

June 21, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2021

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations