- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05430789
Post-discharge Cessation for Smoking Patients
Nurse-led Post-discharge Cessation Support for Smoking Patients Using Mobile-based Intervention: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Most smoking patients continue to smoke (76.1%) after being discharged from hospitals. Post-discharge smoking cessation (SC) support is one of the most cost-effective treatments. Hospitalisation offers a teachable moment to motivate patients to engage in post-discharge intervention, particularly those suffering from smoking-related diseases. Behavioral and psychosocial support increases abstinence in patients. Current clinical guidelines in the US (USPSTF) and UK (NICE) recommend health care professionals to provide brief SC support to patients using a brief advice model such as the 5As (Ask, Assess, Advice, Assist, Arrange) and further motivational 5Rs interventions (Relevance, Risks, Rewards, Roadblocks, and Repetition) if needed for those not having quit attempts. A key trial found that providing discharged patients with such proactive and sustained care as free SC medication, telephone calls to promote quitting, and additional counselling through clinic referrals increased 6-months validated quitting. Trained patient navigators providing patients in hospital primary clinics with tailored individual advice with medication and counselling referrals were found to be effective at improving 12-months quitting. Previous trials also showed connecting community smokers or smokers who visited emergency departments to existing SC services increased validated quitting at 6-months. Recent advances in mobile phone technology allow incorporating such innovations to improve the cost-effectiveness of post-discharge smoking cessation services.
Mobile phones are increasingly used for monitoring and delivering personalised health treatments (mHealth). Regular text messaging was found to increased 6-months validated abstinence in general smokers, although the study was limited to pre-defined messages and interactions. A previous study reported an automated interactive voice response to be favored by patients and to increase abstinence. A text-based programme was tested in a Chinese population, and previous study found the delivery of interactive chat-based SC support via IM apps to be effective in increasing quitting. Chat-based SC interventions can provide real-time, personalised behavioral support and referrals to SC services. Mobile health is also part of the World Health Organization's strategies to combat smoking.
Leveraging the success of previous trials in inpatients and a chat-based trial using IM to deliver behavioral support to community smokers, This study proposes to refine the 5As cessation model by incorporating a mobile phone-based intervention for patients recently discharged from hospitals. Recent trials showed a mobile phone-delivered cessation intervention combined with SC medication service increased abstinence. Recent trials showed a mobile phone-delivered cessation intervention combined with SC medication service increased abstinence. Active referral of community smokers to smoking cessation services increases service use and quitting but smoking patients were not referred for sustained cessation service in hospitals in Hong Kong. The effect of mobile phone-based intervention with active referral to link discharged patients for standard smoking cessation service remains unclear. Therefore, This study proposes to enhance the general 5As brief advice model with interactive mobile phone-based intervention and active referral to community smoking cessation services for smoking patients discharged from hospitals in Hong Kong.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Man Ping Wang, PhD
- Phone Number: +852 3917 6636
- Email: mpwang@hku.hk
Study Contact Backup
- Name: Yingpei Zeng, MNurs
- Phone Number: +852 3917 6649
- Email: ypzeng@connect.hku.hk
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, China
- Recruiting
- School of Nursing, The University of Hong Kong
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Contact:
- Man Ping Wang, PhD
- Email: mpwang@hku.hk
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Contact:
- Yingpei Zeng, MNurs
- Email: ypzeng@connect.hku.hk
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Sub-Investigator:
- Shengzhi Zhao, PhD
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Sub-Investigator:
- Yingpei Zeng, MNurs
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Smokers who are hospitalised or waiting for discharge in Hong Kong
- Smoke cigarettes or alternative tobacco products (e.g. electronic cigarettes or heated tobacco products) daily at 1 month prior to hospitalisation
- Have a smartphone with an IM app (WhatsApp or WeChat) and experience in using the app
- Hong Kong adult residents (18+) able to communicate in Chinese (Cantonese or Mandarin)
Exclusion Criteria:
- Smokers not mentally fit for communication (e.g. psychiatry patients)
- Smokers currently using SC medication or other SC services
- Smokers hospitalised for more than 1 month
- Perceived difficulty to use IM after discharge
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
5As brief advice + Self-help ebooklet + Nurse-led mHealth intervention
|
Participants will receive brief face-to-face advice following a 5As model at baseline:
A 12-page generic self-help smoking cessation e-booklet via IM apps, including:
Participants will receive real-time mHealth behaviour and psychosocial support for 12 weeks after baseline through IM apps.
mHealth intervention consists of two main parts: regular instant messaging on smoking cessation and personalized real-time mHealth chatting on smoking and disease (including active referral to smoking cessation service)
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Active Comparator: Control group
5As brief advice + Self-help ebooklet + Text messaging
|
Participants will receive brief face-to-face advice following a 5As model at baseline:
A 12-page generic self-help smoking cessation e-booklet via IM apps, including:
Participants will receive text messages using IM app with content on general health and reminding the importance of participating in the follow-up surveys and biochemical validation for quitting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemically-validated abstinence
Time Frame: 6-month after baseline
|
Defined by exhaled carbon monoxide < 4 parts per million (ppm) and salivary cotinine < 30 ng/ml
|
6-month after baseline
|
Biochemically-validated abstinence
Time Frame: 12-month after baseline
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Defined by exhaled carbon monoxide < 4 parts per million (ppm) and salivary cotinine < 30 ng/ml
|
12-month after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported past 7-day abstinence
Time Frame: 6-month after baseline
|
Being completely smoke-free in the past 7 days
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6-month after baseline
|
Self-reported past 7-day abstinence
Time Frame: 12-month after baseline
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Being completely smoke-free in the past 7 days
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12-month after baseline
|
24-weeks continuous abstinence
Time Frame: 6-month after baseline
|
Being completely smoke-free in the past 24 weeks
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6-month after baseline
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24-weeks continuous abstinence
Time Frame: 12-month after baseline
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Being completely smoke-free in the past 24 weeks
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12-month after baseline
|
Intention to quit
Time Frame: 6-month after baseline
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A single item will measure if smokers plan to quit smoking in 30 days, with response of yes or no
|
6-month after baseline
|
Intention to quit
Time Frame: 12-month after baseline
|
A single item will measure if smokers plan to quit smoking in 30 days, with response of yes or no
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12-month after baseline
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Number of quit attempt
Time Frame: 6-month after baseline
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Defined by abstinence for at least 24 hours
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6-month after baseline
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Number of quit attempt
Time Frame: 12-month after baseline
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Defined by abstinence for at least 24 hours
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12-month after baseline
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Smoking reduction
Time Frame: 6-month after baseline
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Defined by at least 50% self-reported reduction in baseline daily number of cigarettes
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6-month after baseline
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Smoking reduction
Time Frame: 12-month after baseline
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Defined by at least 50% self-reported reduction in baseline daily number of cigarettes
|
12-month after baseline
|
Nicotine dependence level
Time Frame: 6-month after baseline
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Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)
|
6-month after baseline
|
Nicotine dependence level
Time Frame: 12-month after baseline
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Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)
|
12-month after baseline
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Smoking cessation service use
Time Frame: 6-month after baseline
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Any access to a smoking cessation service
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6-month after baseline
|
Smoking cessation service use
Time Frame: 12-month after baseline
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Any access to a smoking cessation service
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12-month after baseline
|
Collaborators and Investigators
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
Keywords
Other Study ID Numbers
- SC discharge
- HKU Clinical Trials Registry (Registry Identifier: 17614621)
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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