- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04088539
Promoting Smoking Cessation in the Correctional Institutions
Building Capacity and Promoting Smoking Cessation in the Correctional Institutions
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong.
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The specific objectives of the study are:
- To test the effectiveness of face-to-face brief cessation advice and video education for smoking cessation among current smokers at the correctional institutions in Hong Kong;
- To evaluate the process and outcome of the recruitment of smokers through qualitative interviews; and
- To conduct qualitative interviews with quitters and non-quitters to examine their experience on the intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although smoking prevalence is decreasing in Hong Kong, there are still 615,000 daily cigarette smokers in Hong Kong in 2017 and half will be killed by smoking [5] which accounts for over 7,000 deaths per year. Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. Despite the low smoking rate in the general population, smoking prevalence remain high in the correctional institutions. Incarcerated prisoners suffer disproportionately from mental illness, substance use disorders and disease infections. They are in need of health care such as treatment or prevention for smoking. There is a lack of evidence on the effectiveness of smoking cessation intervention in the correctional setting. More work is required to provide smoking cessation assistance to these high risk and underserved population.
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The specific objectives of the study are:
- To test the effectiveness of face-to-face brief cessation advice and video education for smoking cessation among current smokers at the correctional institutions in Hong Kong;
- To evaluate the process and outcome of the recruitment of smokers through qualitative interviews; and
- To conduct qualitative interviews with quitters and non-quitters to examine their experience on the intervention.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- School of Nursing, The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hong Kong residents aged 18 or above
- Smoke at least 1 cigarette per day in the past 3 months
- Able to communicate in Cantonese (including reading Chinese)
- Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
- Intent to quit / reduce smoking
Exclusion Criteria:
- Smokers who have difficulties (either physical or cognitive condition) to communicate
- Currently following other smoking cessation programs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
CSD participants will receive a combined intervention:
|
Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date)
Educational videos on smoking and health will be developed to improve the knowledge of CSD smokers.
The videos aim to raise their awareness on these important health topics and acquire effective cessation methods.
The effectiveness of the educational videos will be evaluated by pre- and post-tests through a self-administered survey that assess the changes in knowledge related to smoking hazards, benefits of quitting, and methods to quit smoking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical validated quit rate at 6-month follow-up
Time Frame: 6-month follow-up
|
The primary outcome is biochemically validated quit rates (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) at 6-month
|
6-month follow-up
|
Biochemical validated quit rate at 3-month follow-up
Time Frame: 3-month follow-up
|
The primary outcome is biochemically validated quit rates (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) at 3-month
|
3-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking quit rate change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
|
Self-reported 7-day point prevalence (pp) quit rate at 3-month
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3-month follow-up
|
Smoking quit rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
|
Self-reported 7-day point prevalence (pp) quit rate at 6-month
|
6-month follow-up
|
Smoking reduction rate change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
|
Rate of smoking reduction by at least half of baseline amount
|
3-month follow-up
|
Smoking reduction rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
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Rate of smoking reduction by at least half of baseline amount
|
6-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CSD 2019-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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