NCT04409496

Brief Summary

This pilot trial aims to evaluate the effectiveness of chat-based instant messaging support in preventing smoking relapse in recent tobacco abstainers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 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 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

May 26, 2020

Last Update Submit

March 2, 2021

Conditions

Smoking Cessation

Keywords

Instant messagingRelapse preventionWhatsAppWeChatChat interventionChineseMobile health

Outcome Measures

Primary Outcomes (1)

  • Biochemically-validated tobacco abstinence

    Defined by an exhaled carbon monoxide level of 3 parts per million or below

    Assessed at 6 months after randomisation

Secondary Outcomes (5)

  • Self-reported 6-month prolonged tobacco abstinence

    Assessed at 6 months after randomisation

  • Self-reported 7-day point-prevalence tobacco abstinence

    Assessed at 3 months after randomisation

  • Self-reported 7-day point-prevalence tobacco abstinence

    Assessed at 6 months after randomisation

  • Self-reported relapse rate

    Assessed at 3 months after randomisation

  • Self-reported relapse rate

    Assessed at 6 months after randomisation

Other Outcomes (4)

  • Change in self-efficacy to quit smoking

    Assessed at 3 months after randomisation

  • Change in self-efficacy to quit smoking

    Assessed at 6 months after randomisation

  • Nicotine withdrawal

    Assessed at 3 months after randomisation

  • +1 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Chat-based instant messaging support + Self-help booklet

Behavioral: Chat-based instant messaging supportBehavioral: Self-help booklet

Control group

ACTIVE COMPARATOR

SMS message support + Self-help booklet

Behavioral: SMS message supportBehavioral: Self-help booklet

Interventions

Chat-based instant messaging supportBEHAVIORAL

Subjects will receive personalised instant messaging support for 12 weeks after baseline, address the five problems that contributed to smoking relapse: (1) lack of support for cessation, (2) negative mood or depression, (3) strong or prolonged withdrawal symptoms, (4) weight gain, and (5) smoking lapses. Updated information about the negative effect of smoking on risk of COVID-19 infection and prognosis will also be delivered.

Intervention group
SMS message supportBEHAVIORAL

Subjects will receive regular SMS on generic smoking cessation for 3 months.

Control group
Self-help bookletBEHAVIORAL

Subjects will receive a standard self-help booklet on smoking relapse prevention.

Control groupIntervention group

Eligibility Criteria

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

You may qualify if:

  • Hong Kong residents aged 18 years or older
  • Enrolled in a smoking cessation programme under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
  • Daily tobacco use before service intake
  • Not using any tobacco product for 3 to 30 days
  • Own a mobile phone with a mobile instant messaging app (WhatsApp or WeChat) installed
  • Able to communicate in Chinese (Cantonese or Mandarin)

You may not qualify if:

  • Subjects with communication barriers owing to physical or cognitive conditions will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation

Hong Kong, Hong Kong

Location

Related Publications (6)

  • Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.

    PMID: 23343063BACKGROUND

  • Patanavanich R, Glantz SA. Smoking Is Associated With COVID-19 Progression: A Meta-analysis. Nicotine Tob Res. 2020 Aug 24;22(9):1653-1656. doi: 10.1093/ntr/ntaa082.

    PMID: 32399563BACKGROUND

  • Patwardhan P. COVID-19: Risk of increase in smoking rates among England's 6 million smokers and relapse among England's 11 million ex-smokers. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101067. doi: 10.3399/bjgpopen20X101067. Print 2020. No abstract available.

    PMID: 32265183BACKGROUND

  • Luk TT, Wong SW, Lee JJ, Chan SS, Lam TH, Wang MP. Exploring Community Smokers' Perspectives for Developing a Chat-Based Smoking Cessation Intervention Delivered Through Mobile Instant Messaging: Qualitative Study. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11954. doi: 10.2196/11954.

    PMID: 30702431BACKGROUND

  • Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31.

    PMID: 33323188BACKGROUND

  • Luk TT, Cheung YTD, Chan HC, Fok PW, Ho KS, Sze CD, Lam TH, Wang MP. Mobile Chat Messaging for Preventing Smoking Relapse Amid the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2023 Jan 5;25(2):291-297. doi: 10.1093/ntr/ntac045.

    PMID: 35166327DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Tzu Tsun Luk, PhD, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 1, 2020

Study Start

June 2, 2020

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)