Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers

Not Applicable

Completed

• Conditions: Smoking Cessation; Tobacco Use Cessation
• Interventions: Behavioral: Brief advice (AWARD model); Behavioral: Regular SMS message; Drug: NRT-S; Behavioral: IM Apps and Chatbot

• Registration Number: NCT04001972
• Lead Sponsor: The University of Hong Kong

Brief Summary

Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S).

Detailed Description

Objectives: Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S).

Design and subjects: Pragmatic, individual randomized controlled trial in 664 daily smokers proactively recruited in smoking hotspots in Hong Kong.

Interventions: Subjects in the Intervention group will receive face-to-face brief advice (including SC services referral) using AWARD model and 1-week free NRT sample (NRT-S) at baseline; and 12-week personalized behavioral support using interactive communication technologies (include regular tailored messages on abstinence, and synchronous IM Apps \[e.g. WhatsApp\] conversation with trained SC advisors and a Chatbot). Subjects in the Control group will receive the same AWARD advice without NRT-S at baseline, and regular short-message-service messages on general health and reminders to participate in follow-up.

Main outcome measures: Primary outcomes are carbon monoxide validated smoking abstinence at 6-month and 12-month. Secondary outcomes include self-reported past 7-day abstinence, smoking reduction, quit attempt, SC services use, NRT use, self-efficacy on quitting and quality of life.

Data analysis: Intention-to-treat and cost-effectiveness analyses will be conducted. Mediation analyses will explore the underlying mechanisms of Chatbot and IM Apps behavioral support to promote quitting. Individual interviews with quitters and non-quitters, and content analysis of Chatbot/IM Apps will be conducted to have in-depth understanding on the effects of intervention on various outcomes.

Expected results: The Intervention group will have statistically significant higher validated smoking abstinence rates than the Control group at 6-month and 12-month.

Study Timeline

• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Study Start: 2019-08-19
• Primary Completion: 2021-05-08
• Study Completion: 2021-09-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

Inclusion Criteria

1. Adult smokers aged 18+ years who smoke cigarette(s) daily.
2. Exhaled carbon monoxide (CO) level of ≥ 4ppm.
3. Having smartphones and willing to install IM Apps and a Chatbot.
4. Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).

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Exclusion Criteria

1. Smokers who have psychiatric/psychological diseases/on regular psychotropic medications.
2. Smokers who are using SC medication, NRT, other SC services or projects.
3. Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant <6 months) or breastfeeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	IM Apps and Chatbot	Brief advice (AWARD model) + NRT-S + IM Apps and Chatbot
Control group	Brief advice (AWARD model)	Brief advice (AWARD model) + regular SMS
Control group	Regular SMS message	Brief advice (AWARD model) + regular SMS
Intervention group	Brief advice (AWARD model)	Brief advice (AWARD model) + NRT-S + IM Apps and Chatbot
Intervention group	NRT-S	Brief advice (AWARD model) + NRT-S + IM Apps and Chatbot

Primary Outcome Measures

Name	Time	Method
Biochemically validated abstinence of NRT-S +IM Apps and Chatbot vs. regular SMS	At 12-month follow-up	NRT-S +IM Apps and Chatbot vs. regular SMS on validated abstinence defined as exhaled carbon monoxide \<4ppm

Secondary Outcome Measures

Name	Time	Method
Self-reported 7-day point prevalence abstinence	At 12-month follow-up	Self-reported no cigarette smoking (even a single puff) in the past 7 days
Self-reported past 24-week continuous abstinence	At 12-month follow-up	Self-reported no cigarette smoking (even a single puff) in the past 24 weeks
Planned quit day	At 12-month follow-up	Planned quit day with responses "within 7 days/within 30 days/within 60 days/undecided"
Change in number of quit attempts from baseline	At 12-month follow-up	Defined by abstinence for at least 24 hours from baseline
Any use of nicotine replacement therapy	At 12-month follow-up	Any use of nicotine replacement therapy with responses "yes/no"
Change in quality-adjusted life year (QALY)	At 12-month follow-up	Change in quality-adjusted life year (QALY) will be estimated using the validated Chinese five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
Change in smoking reduction rate from baseline	At 12-month follow-up	Defined by at least 50% reduction in baseline daily number of cigarettes
Change in micotine addiction level from baseline	At 12-month follow-up	Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)
Any access to a smoking cessation service	At 12-month follow-up	Any access to a smoking cessation service with responses "yes/no"

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong