Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers

NCT04001972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2022-05-23

No results posted yet for this study

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

Interventions

BEHAVIORAL

Brief advice (AWARD model)

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.

DRUG

NRT-S

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.

BEHAVIORAL

IM Apps and Chatbot

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.

BEHAVIORAL

Regular SMS message

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

Sponsors & Collaborators

  • Food and Health Bureau, Hong Kong

    collaborator OTHER_GOV
  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Man Ping Wang, PhD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2021-05-08
Completion
2021-09-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001972 on ClinicalTrials.gov