Effectiveness of WhatsApp Online Group Discussion for Smoking Relapse Prevention: a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 928
- 试验地点
- 1
- 主要终点
- Number of Participants Who Passed the Biochemical Validated Abstinence at 12-month Follow-up
研究概览
简要总结
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.
详细描述
Study design:
This is a 2-arm open-labelled pragmatic randomized controlled trial, by comparing the 12-month tobacco abstinence between the recent quitters who will join WhatsApp group discussion (Intervention group) and those who will not (Control group). A 1:1 randomised allocation will be used. The intervention content for both trial arms in the proposed trial will be the same and based on the US practice guidelines for smoking cessation, therefore the intervention effects due to the treatment content will be the same in both groups. Only the intervention platform (WhatsApp vs text messaging service) and the communication mode (one-way vs interactive) will be different between the 2 groups. This trial will be a pragmatic effectiveness trial to examine the effect of our intervention delivered under a real-life setting. A less stringent eligibility criteria will be applied for the subjects, unobtrusive measurement on adherence, and include all subjects in the final analysis regardless of intervention compliance of each subject.
Subjects:
Patients who are receiving the smoking cessation service in the smoking cessation clinic of the Queen Elizabeth Hospital, Tung Wah Groups of Hospital, Shau Kei Wan Jockey Club Outpatient Clinic, Sai Ying Pun Jockey Club Outpatient Clinic and Pok Oi Chinese medicine clinic. Smoking Cessation Service will be invited to go through the screening process. These clinics are under Hospital Authority (n=3), or are non-governmental organizations that are funded by the government (n=7). Patients with the following inclusion criteria will be invited to participate in the RCT and will proceed to the recruitment procedure and intervention phase (Phase 2).
- 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 The 4th criterion will be used because our proposed RCT will target the quitters who have recently quit, and exclude those who will have maintained a longer period of abstinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants Who Passed the Biochemical Validated Abstinence at 12-month Follow-up
时间窗: 12 month
Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit
次要结局
- Number of Participants Who Reported Smoking Relapse at 3-month Follow-up(3 month)
- Number of Participants Who Passed the Biochemical Validated Abstinence at 6-month Follow-up(6 month)
- Number of Participants Who Reported Smoking Relapse at 6-month Follow-up(6 month)
- Number of Participants Who Reported Smoking Relapse at 12-month Follow-up(12 month)
- Number of Participants Who Self-reported Continuous Abstinence(12 month)
- Number of Participants Who Self-reported 7-day Abstinence at 3-month Follow-up(3 month)
- Number of Participants Self-reported 7-day Abstinence at 6-month Follow-up(6 month)
- Number of Participants Self-reported 7-day Abstinence at 12-month Follow-up(12 month)
- Number of Participants Who Reported Self-reported Continuous Abstinence(3 month)
研究者
Dr. Derek Yee-Tak Cheung
Research Assistant Professor
The University of Hong Kong