- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06234475
Smoking Cessation Program for the Older Smokers
A Randomized 2 by 2 Factorial Trial on mHealth Support and Financial Incentives to Promote Smoking Cessation in Deprived Older Smokers
Study Overview
Status
Conditions
Detailed Description
Low-income older smokers are disproportionally harmed by tobacco use and the evidence of effectiveness of smoking cessation (SC) intervention for this deprived group is scarce. Leveraging evidence of effectiveness of mHealth support and financial incentives in other adults, the investigators propose a scalable mHealth and/or financial incentives model using age-friendly components for the deprived older smokers.
The 2x2 factorial design consists of 2 interventions, including (1) smartphone mHealth support by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months, and (2) an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.
The study aims to assess the effectiveness of two interventions and their interactive intervention effect.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- School of Nursing, The University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Smokers aged 60 years or above;
- Currently smoking cigarettes or alternative tobacco products daily in the past 3 months with an exhaled carbon monoxide (CO) level ≥4ppm or salivary cotinine >30 ng/ml;
- Have a mobile phone that can receive short message/messaging Service (SMS) or instant messages (IM);
- Having a household monthly income lower than the median income of domestic household in Hong Kong
6. Hong Kong residents able to communicate in Chinese.
Exclusion Criteria:
- Smokers not physically nor mentally fit for communication;
- Smokers currently using SC services;
- Hospitalized smokers;
- Not having a mobile phone or perceived difficulty in using mobile phone or communication Apps
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mobile health group
Smartphone mHealth support for smoking cessation by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months.
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Experimental: Financial incentive group
An escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.
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Experimental: Combined intervention group
Smartphone mHealth support for smoking cessation by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months and an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.
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Active Comparator: Control group
Brief advice
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The biochemically validated smoking abstinence
Time Frame: the 6-month follow-ups
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Smoking abstinence is defined by exhaled CO < 4 ppm and salivary cotinine <30 ng/ml
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the 6-month follow-ups
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The biochemically validated smoking abstinence
Time Frame: the 3- and 12-month follow-ups
|
Smoking abstinence is defined by exhaled CO < 4 ppm and salivary cotinine <30 ng/ml
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the 3- and 12-month follow-ups
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Self-reported 7-day point-prevalence abstinence
Time Frame: 3-, 6-, and 12-month follow-ups
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Smokers who did not smoke even a puff in the 7 days preceding the follow-up
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3-, 6-, and 12-month follow-ups
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Self-reported quit attempts
Time Frame: 3-, 6-, and 12-month follow-ups
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Self-reported quit attempt
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3-, 6-, and 12-month follow-ups
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Smoking cessation services use
Time Frame: 3-, 6-, and 12-month follow-ups
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Using the smoking cessation service from hospitals or government in Hong Kong
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3-, 6-, and 12-month follow-ups
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Self-reported intention to quit
Time Frame: 3-, 6-, and 12-month follow-ups
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self-reported intention to quit in next days
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3-, 6-, and 12-month follow-ups
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Self-reported smoking change
Time Frame: 3-, 6-, and 12-month follow-ups
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Self-reported change in number of cigarettes smoked daily of at least less 50% of the baseline number
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3-, 6-, and 12-month follow-ups
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Self-reported self-efficacy of quitting
Time Frame: 3-, 6-, and 12-month follow-ups
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Self-reported self-efficacy of quitting includes the perception of quitting importance, difficulty and confidence, assessing by an item scaled with 0-10, respectively.
The score of zero refers to very unimportant, very easy, or very unconfident.
The score of 10 refers to very important, very difficult or very confident, respectively.
Higher score refers to higher perception of quitting importance, difficulty and confidence.
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3-, 6-, and 12-month follow-ups
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Nicotine dependence level
Time Frame: 3-, 6-, and 12-month follow-ups
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Fagerstrom Test for Nicotine Dependence (FTND)
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3-, 6-, and 12-month follow-ups
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCFO
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
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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