Mixed and Match vs One-size-fits-all
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Mixed and Match Participants can choose to receive their own smoking cessation treatment options from our menu. |
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 will receive a self-help quitting leaflet |
Other: Control
Participants in the control group will receive a self-help quitting leaflet issued by the TACO
|
Outcome Measures
Primary Outcome Measures
- Self-reported abstinence at 6-month follow-up [At 6-month follow-up]
participants will be asked about their self-reported abstinence in the past 7 and 30 days
- Biochemically validated abstinence [At 6 months follow-up]
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
- Self-efficacy at 6-month follow-up [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.
Secondary Outcome Measures
- Screening rate [at day 1]
calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available
- Eligibility rate [at day 1]
calculated by dividing the number of smokers who are eligible by the number who are screened.
- Randomization rate [at day 1]
calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent.
- Attendance rate [Immediately after the training workshop]
calculated by dividing the number of smokers who complete the intervention by those who are randomized.
- Retention rate at 1-week follow-up [At 1-week follow-up]
calculated by dividing the number of smokers who remain in the study by those who are randomized
- Retention rate at 1-month follow-up [At 1-month follow-up]
calculated by dividing the number of smokers who remain in the study by those who are randomized
- Retention rate at 6-month follow-up [At 6-month follow-up]
calculated by dividing the number of smokers who remain in the study by those who are randomized
- Retention rate at 3-month follow-up [At 3-month follow-up]
calculated by dividing the number of smokers who remain in the study by those who are randomized
- Adherence to intervention protocol at 1-week follow-up [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
- Adherence to intervention protocol at 1-month follow-up [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
- Adherence to intervention protocol at 3-month follow-up [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
- Adherence to intervention protocol at 6-month follow-up [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
- Complete rate at 1-week follow-up [At 1-week follow-up]
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
- Complete rate at 1-month follow-up [At 1-month follow-up]
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
- Complete rate at 3-month follow-up [At 3-month follow-up]
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
- Complete rate at 6-month follow-up [At 6-month follow-up]
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
- Missing data at 1-week follow-up [At 1-week follow-up]
calculated as the percentage of missing values in the dataset
- Missing data at 1-month follow-up [At 1-month follow-up]
calculated as the percentage of missing values in the dataset
- Missing data at 3-month follow-up [At 3-month follow-up]
calculated as the percentage of missing values in the dataset
- Missing data at 6-month follow-up [At 6-month follow-up]
calculated as the percentage of missing values in the dataset
- Adverse events at 6-month follow-up [At 6-month follow-up]
Participants will report any unfavorable and unintended events
- Adverse events at 1-week follow-up [At 1-week follow-up]
Participants will report any unfavorable and unintended events
- Adverse events at 1-month follow-up [At 1-month follow-up]
Participants will report any unfavorable and unintended events
- Adverse events at 3-month follow-up [At 3-month follow-up]
Participants will report any unfavorable and unintended events
- Self-reported abstinence at 1-week follow-up [At 1-week follow-up]
Participants will be asked about their self-reported abstinence in the past 7 and 30 days
- Self-reported abstinence at 1-month follow-up [At 1-month follow-up]
participants will be asked about their self-reported abstinence in the past 7 and 30 days
- Self-reported abstinence at 3-month follow-up [At 3-month follow-up]
participants will be asked about their self-reported abstinence in the past 7 and 30 days
- Self-efficacy at 1-week follow-up [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.
- Self-efficacy at 1-month follow-up [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.
- Self-efficacy at 3-month follow-up [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Hong Kong Polytechnic University
Investigators
- Principal Investigator: Katherine Lam, PhD, The Hong Kong Polytechnic University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SDTM-adult