Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers

NCT04001972 | Completed DMC

• 1 other identifier: ICTNRT
• Study Type: interventional
• Target: 664
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking Cessation; Tobacco Use Cessation

Keywords

tobacco dependence treatment; combined brief intervention; AWARD advice; active referral; nicotine replacement therapy; information and communication technologies

Outcome Measures

Primary Outcomes (2)

• Biochemically validated abstinence of NRT-S +IM Apps and Chatbot vs. regular SMS

  NRT-S +IM Apps and Chatbot vs. regular SMS on validated abstinence defined as exhaled carbon monoxide \<4ppm

  At 6-month follow-up

• Biochemically validated abstinence of NRT-S +IM Apps and Chatbot vs. regular SMS

  NRT-S +IM Apps and Chatbot vs. regular SMS on validated abstinence defined as exhaled carbon monoxide \<4ppm

  At 12-month follow-up

Secondary Outcomes (17)

• Self-reported 7-day point prevalence abstinence

  At 6-month follow-up

• Self-reported 7-day point prevalence abstinence

  At 12-month follow-up

• Self-reported past 24-week continuous abstinence

  At 6-month follow-up

• Self-reported past 24-week continuous abstinence

  At 12-month follow-up

• Planned quit day

  At 6-month follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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

Control group

ACTIVE COMPARATOR

Brief advice (AWARD model) + regular SMS

Behavioral: Brief advice (AWARD model); Behavioral: Regular SMS message

Interventions

Brief advice (AWARD model) BEHAVIORAL

Ask: smoking habit, quit intention and attempt, smoking reduction intention, previous quitting experience including NRT and SC use. Warn: smokers will be orally warned about the harms of smoking and receive a A5-sized leaflet, which includes some shocking pictures of smoking-related diseases, and SC services information. Advise: smokers will be advised to quit as soon as possible and use NRT or SC services. Refer: smokers will be encouraged to seek SC services for free NRT or other SC services. Those who agreed will be actively referred to their preferred SC services. The collected contact information with consent will be sent to the SC services providers for a quick appointment and follow-up. Do-it-again: Relapsed smokers (identified during follow-ups and IM conversation) will receive the "Advise" and "Refer" intervention.

Also known as: Ask, Warn, Advise, Refer and Do-it-again

Control group; Intervention group

NRT-S DRUG

One-week free NRT (gum or patch) will be provided with dosage based on time to first cigarette smoking after waking up in the morning and previous NRT use (standard practice and according to specific NRT product instructions). Subjects who have first cigarette \<30 minutes in the morning or have previously used NRT, will receive 4mg nicotine gum or 21mg nicotine patch. Those who have first cigarette \>30 minutes after waking up and have not previously used NRT will receive 2mg nicotine gum or 14mg nicotine patch. NRT use and potential side effects will be briefly explained orally based on standardized script according to the product instructions. An NRT use card containing reminders of NRT use and potential side effects will be given.

Also known as: NRT sample

Intervention group

IM Apps and Chatbot BEHAVIORAL

Twelve-week personalized behavioral support will be delivered using interactive communication technologies using (1) regular tailored messages on abstinence, and (2) synchronous IM Apps conversation with trained SC advisors, and (3) a Chatbot: A Chatbot will be built using open source NLP and machine intelligence platforms. The unstructured text data from our previous study (ClinicalTrials.gov ID: NCT03182790) will be used to train the proposed Chatbot. We will draft responses for each identified question. The final version will be incorporated with Application Programming Interface (API) integration into user-friendly apps (iOS/Android/web app) with a backend server support and continuous data collection for potential bigdata analysis.

Intervention group

Regular SMS message BEHAVIORAL

Regular SMS messages focus on general health and remind the importance of participating in the follow-up surveys and biochemical validation for quitting

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Food and Health Bureau, Hong Kong: collaborator

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• Guo N, Luk TT, Wu YS, Guo Z, Chu JCL, Cheung YTD, Chan CHH, Kwok TTO, Wong VYL, Wong CKH, Lee JJ, Kwok YK, Viswanath K, Lam TH, Wang MP. Effect of mobile interventions with nicotine replacement therapy sampling on long-term smoking cessation in community smokers: A pragmatic randomized clinical trial. Tob Induc Dis. 2023 Mar 24;21:44. doi: 10.18332/tid/160168. eCollection 2023.

  PMID: 36969982 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Cessation

Interventions

Crisis Intervention; corticosteroid hormone-induced factor; Referral and Consultation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Man Ping Wang, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 28, 2019
• Study Start: August 19, 2019
• Primary Completion: May 8, 2021
• Study Completion: September 30, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)