Smoking Cessation Clinical Trial
Official title:
Effectiveness of WhatsApp Online Group Discussion for Smoking Relapse Prevention: a Pragmatic Randomized Controlled Trial
Verified date | March 2022 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to examine the effectiveness and cost-effectiveness of WhatsApp group discussion for smoking relapse prevention. To assess the effect due to treatment modality through the WhatsApp social group, the frequency and topics of the posts in each social group will be analysed and in each participant. The primary hypothesis is whether quitters who participate in the WhatsApp group discussion will have a higher prevalence of validated tobacco abstinence at 12-month follow-up than those who do not. The second hypothesis is that greater participation in the social groups, indicated by number of posts received, posted and/or viewed, was associated with higher likelihood to quit at 12-month. The third hypothesis is that the WhatsApp intervention for a recent quitter is a more cost-effective option for tobacco abstinence and prolonged survival when compared to the control group.
Status | Completed |
Enrollment | 928 |
Est. completion date | June 30, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Daily tobacco user before service intake - Aged 18 years or above - Have enrolled or re-enrolled in the smoking cessation treatment for no more than 8 weeks - Not using tobacco products (including traditional cigarettes and heat-not-burn tobacco products) for 3 to 30 days - Able to communicate in Cantonese/Mandarin and read Chinese - Have a smart phone with local network connection Exclusion Criteria: - Do not use WhatsApp as communication tool and show no interest to use WhatsApp - Have unstable physical or psychological conditions as advised by doctors or counsellor in charge - Have become pregnant in the past 2 months |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Hong Kong University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Frequency of Smoking Urge | Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more). | 3 month | |
Other | Intensity of Smoking Urge | Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more). | 3 month | |
Other | Frequency of Smoking Urge | Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more). | 6 month | |
Other | Intensity of Smoking Urge | Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more). | 6 month | |
Other | Frequency of Smoking Urge | Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more). | 12 month | |
Other | Intensity of Smoking Urge | Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more). | 12 month | |
Other | EuroQoL 5-Dimension 5-Level (EQ-5D-5L) | EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.). | 3 month | |
Other | EuroQoL 5-Dimension 5-Level (EQ-5D-5L) | EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.). | 6 month | |
Other | EuroQoL 5-Dimension 5-Level (EQ-5D-5L) | EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.). | 12 month | |
Other | Change in Quality of Life Inventory | Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family. | 6 month | |
Other | Change in Quality of Life Inventory | Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family. | 12 month | |
Other | Nicotine Withdrawals | Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms. | 3 month | |
Other | Nicotine Withdrawals | Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms. | 6 month | |
Other | Nicotine Withdrawals | Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms. | 12 month | |
Primary | Number of Participants Who Passed the Biochemical Validated Abstinence at 12-month Follow-up | Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit | 12 month | |
Secondary | Number of Participants Who Passed the Biochemical Validated Abstinence at 6-month Follow-up | Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit | 6 month | |
Secondary | Number of Participants Who Self-reported 7-day Abstinence at 3-month Follow-up | Self-reported abstinence in the past 7 days at 3-month follow-up | 3 month | |
Secondary | Number of Participants Self-reported 7-day Abstinence at 6-month Follow-up | Self-reported abstinence in the past 7 days at 6-month follow-up | 6 month | |
Secondary | Number of Participants Self-reported 7-day Abstinence at 12-month Follow-up | Self-reported abstinence in the past 7 days at 12-month follow-up | 12 month | |
Secondary | Number of Participants Who Reported Smoking Relapse at 3-month Follow-up | Consuming 5 cigarettes or more in 3 consecutive days in the past 3 months | 3 month | |
Secondary | Number of Participants Who Reported Smoking Relapse at 6-month Follow-up | Consuming 5 cigarettes or more in 3 consecutive days in the past 6 months | 6 month | |
Secondary | Number of Participants Who Reported Smoking Relapse at 12-month Follow-up | Consuming 5 cigarettes or more in 3 consecutive days in the past 12 months | 12 month | |
Secondary | Number of Participants Who Reported Self-reported Continuous Abstinence | Self-reported continuous abstinence | 3 month | |
Secondary | Number of Participants Who Self-reported Continuous Abstinence | Self-reported continuous abstinence | 6 month | |
Secondary | Number of Participants Who Self-reported Continuous Abstinence | Self-reported continuous abstinence | 12 month |
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