Clinical trial NCT03800719: Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation
Official title: Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation in Smokers Proactively Recruited From Smoking Hotspots in Hong Kong: a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
active referral
IM
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Detailed Description: With the advancement of information communication technologies (ICTs), instant messaging applications (IM Apps, e.g. WhatsApp and WeChat) can be used for providing synchronous, personalized, interactive interventions for health promotion. This study proposes to apply IM Apps for enhancing our tested brief smoking cessation (SC) intervention model from AWARD to e-AWARD (AWARD: Ask, Warn, Advise, Refer, Do-it-again,) without medications to increase SC in smokers proactively recruited in smoking hotspots in Hong Kong. Such smokers are the majority and have low quit rate. IM Apps allows trained SC advisors to proactively deliver personalized SC advices, response to smokers' needs promptly, and provide psychosocial support. No similar trials are found in PubMed, Cochrane Library and trial registries (ClinicalTrials.gov \& ISRCTN) (except the pilot trial of this study). The aims of this study are as follows:

1. To assess the main effect of the personalized support using instant messaging applications (Intervention) vs. Control group on biochemical validated smoking abstinence at 6-month and 12-month.
2. To assess the effects on self-reported past 7-day abstinence, 24-week continuous abstinence, smoking reduction, self-efficacy of quitting, intention to quit, quit attempts and SC medications and services use at 6-month and 12-month.
3. To identify the mediators, which can inform mechanisms of the intervention on SC.
4. To evaluate the cost-effectiveness of the above interventions.
5. To understand the effects subjects' experience of IM support on SC using a qualitative study approach.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

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

Primary outcomes:
measure: Biochemically-validated abstinence at 6-month
timeFrame: 6-month after baseline
measure: Biochemically-validated abstinence at 12-month
timeFrame: 12-month after baseline
Secondary outcomes:
measure: Self-reported past 7-day abstinence
timeFrame: 6-month and 12-month after baseline
measure: Self-reported 24-week continuous abstinence
timeFrame: 6-month and 12-month after baseline
measure: Smoking reduction
timeFrame: 6-month and 12-month after baseline
measure: Perceived importance, confidence and difficulties of quitting
timeFrame: 6-month and 12-month after baseline
measure: Intention to quit
timeFrame: 6-month and 12-month after baseline
measure: Quit attempts
timeFrame: 6-month and 12-month after baseline
measure: Smoking cessation medication use
timeFrame: 6-month and 12-month after baseline
measure: Smocking cessation services use
timeFrame: 6-month and 12-month after baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
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