Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers

The University of Hong Kong (HKU)

Status: Completed

Conditions: Tobacco Use Cessation; Smoking Cessation

Treatments: Behavioral: Brief advice (AWARD model); Behavioral: IM Apps and Chatbot; Behavioral: Regular SMS message; Drug: NRT-S

Study type: Interventional

Funder types: Other

Identifiers

NCT04001972

ICTNRT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 664 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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664 participants in 2 patient groups

Intervention group

Experimental group

Description:

Brief advice (AWARD model) + NRT-S + IM Apps and Chatbot

Treatment:

Behavioral: IM Apps and Chatbot

Drug: NRT-S

Behavioral: Brief advice (AWARD model)

Control group

Active Comparator group

Description:

Brief advice (AWARD model) + regular SMS

Treatment:

Behavioral: Regular SMS message

Behavioral: Brief advice (AWARD model)