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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05297370
Other study ID # SDTM-adult
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2023

Study information

Verified date March 2022
Source The Hong Kong Polytechnic University
Contact Katherine Lam, PhD
Phone 27666420
Email kwkatlam@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Most existing smoking cessation services are based on '5A's' and '5R's' models which are recognized by the World Health Organization as a standardized tool for smoking cessation. While there are more techniques that are known to be effective and could be incorporated in existing smoking cessation interventions to further promote their effectiveness. This study is to examine the effectiveness SDTM in assisting adult smokers in Hong Kong to quit.


Description:

A randomized controlled trial (RCT) will be conducted. One-hundred adult smokers aged 25 or above will be recruited from smoking hotspots in Hong Kong. Participants in the intervention group will be contacted by our trained research assistant to receive a telephone counselling session at baseline. Participants can choose to receive their own smoking cessation treatment options from our menu. Control group participants will only receive a self-help quitting leaflet


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years and older
Eligibility Inclusion Criteria: - have smoking in the previous 30 days. - be above 25 years old - able to speak Cantonese and read Chinese Exclusion Criteria: - who are receiving current smoking cessation services - report psychological disorders - at risk of suicide

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mixed and match Intervention
Participants will receive a brief 15-minute counselling session based on the 5A's' and '5R's' models by our trained research assistant. Participants will be able to choose their smoking cessation treatment options from our menu.
Other:
Control
Participants in the control group will receive a self-help quitting leaflet issued by the TACO

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported abstinence at 6-month follow-up participants will be asked about their self-reported abstinence in the past 7 and 30 days At 6-month follow-up
Primary Biochemically validated abstinence validate the self-reported abstinence 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 6 months follow-up
Primary Self-efficacy at 6-month follow-up Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy. At 6-month follow-up
Secondary Screening rate calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available at day 1
Secondary Eligibility rate calculated by dividing the number of smokers who are eligible by the number who are screened. at day 1
Secondary Randomization rate calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent. at day 1
Secondary Attendance rate calculated by dividing the number of smokers who complete the intervention by those who are randomized. Immediately after the training workshop
Secondary Retention rate at 1-week follow-up calculated by dividing the number of smokers who remain in the study by those who are randomized At 1-week follow-up
Secondary Retention rate at 1-month follow-up calculated by dividing the number of smokers who remain in the study by those who are randomized At 1-month follow-up
Secondary Retention rate at 6-month follow-up calculated by dividing the number of smokers who remain in the study by those who are randomized At 6-month follow-up
Secondary Retention rate at 3-month follow-up calculated by dividing the number of smokers who remain in the study by those who are randomized At 3-month follow-up
Secondary Adherence to intervention protocol at 1-week follow-up calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized At 1-week follow-up
Secondary Adherence to intervention protocol at 1-month follow-up calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized At 1-month follow-up
Secondary Adherence to intervention protocol at 3-month follow-up calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized At 3-month follow-up
Secondary Adherence to intervention protocol at 6-month follow-up calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized At 6-month follow-up
Secondary Complete rate at 1-week follow-up calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed At 1-week follow-up
Secondary Complete rate at 1-month follow-up calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed At 1-month follow-up
Secondary Complete rate at 3-month follow-up calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed At 3-month follow-up
Secondary Complete rate at 6-month follow-up calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed At 6-month follow-up
Secondary Missing data at 1-week follow-up calculated as the percentage of missing values in the dataset At 1-week follow-up
Secondary Missing data at 1-month follow-up calculated as the percentage of missing values in the dataset At 1-month follow-up
Secondary Missing data at 3-month follow-up calculated as the percentage of missing values in the dataset At 3-month follow-up
Secondary Missing data at 6-month follow-up calculated as the percentage of missing values in the dataset At 6-month follow-up
Secondary Adverse events at 6-month follow-up Participants will report any unfavorable and unintended events At 6-month follow-up
Secondary Adverse events at 1-week follow-up Participants will report any unfavorable and unintended events At 1-week follow-up
Secondary Adverse events at 1-month follow-up Participants will report any unfavorable and unintended events At 1-month follow-up
Secondary Adverse events at 3-month follow-up Participants will report any unfavorable and unintended events At 3-month follow-up
Secondary Self-reported abstinence at 1-week follow-up Participants will be asked about their self-reported abstinence in the past 7 and 30 days At 1-week follow-up
Secondary Self-reported abstinence at 1-month follow-up participants will be asked about their self-reported abstinence in the past 7 and 30 days At 1-month follow-up
Secondary Self-reported abstinence at 3-month follow-up participants will be asked about their self-reported abstinence in the past 7 and 30 days At 3-month follow-up
Secondary Self-efficacy at 1-week follow-up Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy. at 1-week follow-up
Secondary Self-efficacy at 1-month follow-up Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy. at 1-month follow-up
Secondary Self-efficacy at 3-month follow-up Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy. at 3-month follow-up
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