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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05148520
Other study ID # YQL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date December 1, 2022

Study information

Verified date November 2021
Source The Hong Kong Polytechnic University
Contact Ka Yan Ho, PhD
Phone 27666417
Email kyeva.ho@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project is funded by Department of Health. We will run a quitline which provides telephone smoking cessation counseling to youth smokers aged 25 or below. After baseline counseling based on trans-theoretical model, follow-up counseling will be provided by trained counselors (i.e. nursing students or students from other healthrelated disciplines) at 1 week, 1, 3, 6, 9 and 12 months. It is expected that the quitline can assist youth smokers to quit smoking, thus saving the healthcare cost attributed to smoking in long-term.


Description:

This project will last for 15 months (from 1st Dec 2020 to 28th Feb 2022). Prior to commencement, a month will be spent on preparation, including setting up the quitline and website, designing and printing publicity materials, connecting with secondary and post-secondary schools and training peer counsellors. We will operate the quitline for 15 months and provide telephone counselling for eligible youth smokers. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 25 Years
Eligibility Inclusion Criteria: - Aged 25 or below - Self-reported to smoke any types of tobacco products within the past 1 month - Speak Cantonese and - Provide verbal consent to counselling service. Exclusion Criteria: - have psychiatric disease - and/or currently receive any smoking cessation intervention from other service providers

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
5A's model
(1) Ask - ask youth smokers about their smoking habit, (2) Advise - advise youth smokers to quit smoking, (3) Assess - assess youth smokers about their willingness to quit smoking, (4) Assist - assist youth smokers who are willing to make a quit attempt, and (5) Arrange - arrange for follow-up.

Locations

Country Name City State
Hong Kong Ka Yan Ho Hong Kong Hong Kong,China

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported 7-point prevalence The self-reported abstinence will be validated if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests. at the 6-month follow-up
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