Clinical trial NCT04001972: Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers
Official title: Intervention Combining Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Proactively Recruited Smokers in Smoking Hotspots: a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tobacco Use Cessation
Keywords: tobacco dependence treatment
combined brief intervention
AWARD advice
active referral
nicotine replacement therapy
information and communication technologies
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
First posted: 2019-06-28
Enrollment: 664
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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemically validated abstinence of NRT-S +IM Apps and Chatbot vs. regular SMS
timeFrame: At 6-month follow-up
measure: Biochemically validated abstinence of NRT-S +IM Apps and Chatbot vs. regular SMS
timeFrame: At 12-month follow-up
Secondary outcomes:
measure: Self-reported 7-day point prevalence abstinence
timeFrame: At 6-month follow-up
measure: Self-reported 7-day point prevalence abstinence
timeFrame: At 12-month follow-up
measure: Self-reported past 24-week continuous abstinence
timeFrame: At 6-month follow-up
measure: Self-reported past 24-week continuous abstinence
timeFrame: At 12-month follow-up
measure: Planned quit day
timeFrame: At 6-month follow-up
measure: Planned quit day
timeFrame: At 12-month follow-up
measure: Change in number of quit attempts from baseline
timeFrame: At 6-month follow-up
measure: Change in number of quit attempts from baseline
timeFrame: At 12-month follow-up
measure: Change in smoking reduction rate from baseline
timeFrame: At 6-month follow-up
measure: Change in smoking reduction rate from baseline
timeFrame: At 12-month follow-up
measure: Change in micotine addiction level from baseline
timeFrame: At 6-month follow-up
measure: Change in micotine addiction level from baseline
timeFrame: At 12-month follow-up
measure: Any access to a smoking cessation service
timeFrame: At 6-month follow-up
measure: Any access to a smoking cessation service
timeFrame: At 12-month follow-up
measure: Any use of nicotine replacement therapy
timeFrame: At 6-month follow-up
measure: Any use of nicotine replacement therapy
timeFrame: At 12-month follow-up
measure: Change in quality-adjusted life year (QALY)
timeFrame: At 12-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Man Ping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: