NCT03800719

Brief Summary

This study aims to assess the effect of personalized support using instant messaging application on smoking cessation in smokers proactively recruited from smoking hotspots in Hong Kong.

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
696

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

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

December 15, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

January 8, 2019

Last Update Submit

September 26, 2019

Conditions

Keywords

smoking cessationactive referralIM

Outcome Measures

Primary Outcomes (2)

  • Biochemically-validated abstinence at 6-month

    Defined as exhaled carbon monoxide \<4ppm

    6-month after baseline

  • Biochemically-validated abstinence at 12-month

    Defined as exhaled carbon monoxide \<4ppm

    12-month after baseline

Secondary Outcomes (8)

  • Self-reported past 7-day abstinence

    6-month and 12-month after baseline

  • Self-reported 24-week continuous abstinence

    6-month and 12-month after baseline

  • Smoking reduction

    6-month and 12-month after baseline

  • Perceived importance, confidence and difficulties of quitting

    6-month and 12-month after baseline

  • Intention to quit

    6-month and 12-month after baseline

  • +3 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, regular messages through Instant Messaging (IM), psychosocial support and referral to SC services through IM

Behavioral: AWARD adviceBehavioral: Health warning leafletBehavioral: Active referral to smoking cessation (SC) servicesBehavioral: Regular messages through Instant Messaging (IM)Behavioral: Psychosocial support and referral to SC services through IM

Control Group

ACTIVE COMPARATOR

AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, SMS message on general health

Behavioral: AWARD adviceBehavioral: Health warning leafletBehavioral: Active referral to smoking cessation (SC) servicesBehavioral: Message on general health delivered by short message service (SMS)

Interventions

AWARD adviceBEHAVIORAL

At baseline, brief smoking cessation advice following AWARD model will be delivered to subjects within about 2 to 5 minutes: * Ask about smoking history and habit * Warn about the risks of smoking using a leaflet * Advise to quit smoking as soon as possible and use nicotine replacement therapy (NRT) or SC services * Refer subjects to free smoking cessation services in Hong Kong if they agree * Do it again: smokers who have tried to quit but relapsed will be encouraged to quit again and those who have reduced smoking will be advised to further reduce or quit smoking

Control GroupIntervention Group

At baseline, an A5-sized leaflet will be given to subjects, which includes information about risks of smoking, pictures of smoking-related diseases, and smoking cessation services provided in Hong Kong.

Control GroupIntervention Group

At baseline, subjects will be encouraged to seek smoking cessation services in Hong Kong. If subjects agree, their contact information will be sent to the preferred service providers for a quick appointment and follow-up.

Control GroupIntervention Group

A total of pre-set 26 messages will be sent to subjects through WhatsApp 12 weeks after baseline to remind the quit date and to encourage abstinence. Messages are tailored based on subjects' sociodemographic characteristics and smoking habit following Social Cognitive Theory and Transtheoretical Model. 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. The schedule will be adjusted according to the quit date and also smokers' requests. The format of regular messages will mainly be text-based but also include pictures, animations and videos.

Intervention Group

Personalized interactive text or voice conversation will be provided by trained smoking cessation advisors through WhatsApp for 3 months after baseline. Advisors will periodically proactively send messages to subjects to initiate the conversation (e.g. asking recent progress of smoking cessation) and deliver evidence-based advice. Advisors will also actively refer subjects, if they have expressed the need, to smoking cessation services providers. A standard operation algorithm for advisors used in the pilot feasibility trial will be modified for the use.

Intervention Group

After baseline, regular messages using SMS will be sent to subjects with similar frequency to Intervention group. The messages include information on general health and reminders on follow-up surveys and biochemical validation for quitting.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Adult smokers aged 18+ who smoke cigarette(s) daily.
  • Exhaled carbon monoxide (CO) level of 4ppm or above.
  • Having smartphones with IM Apps (WhatsApp) and have experience in using.
  • Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).

You may not qualify if:

  • Smokers who have psychiatric/psychological diseases or are on regular psychotropic medications.
  • Smokers who are using SC medication, NRT, other SC services or projects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, 000000, Hong Kong

RECRUITING

Related Publications (45)

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MeSH Terms

Conditions

Smoking Cessation

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Fleur Lee, MPhil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 11, 2019

Study Start

December 15, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations