Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- self-reported abstinence in the past 30 days at 2-month follow-up
研究概览
简要总结
This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted.
详细描述
This pilot study includes three phases. The first phase will be a Q-sorting process on the Q-statements which have been developed in the pilot study. Phase 2 will be the development of a typology assessment tool, intervention protocol, and training. Phase 3 will be a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the typology-based intervention. Ethics approval will be obtained from the Institutional Review Board of the University of Hong Kong/Hong Kong Authority Hong Kong West Cluster.
This study protocol complies with the Declaration of Helsinki and the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP).
Phase 1 Q-method study (5 months) In phase 1, ex-smokers will be recruited online and in local community-based SC clinics. Mass mails including study details will be sent to all HKU staff and students. Recruitment ads will also be posted on online platforms such as Google, Facebook, and Instagram. Participants will be directed to an online Qualtrics to complete a brief screening questionnaire and provide their contact information for the sign-up process. SC clinics or services under Tung Wah Group of Hospitals, Pok Oi Hospital, Hospital Authority (HA), and Youth Quitline of the University of Hong Kong, which offer behaviour and/or pharmacological interventions. The investigators have successful experience collaborating with these service providers in recruiting smokers for several projects. For example, the investigators recruited 1,008 ex-smokers from these service providers in an HMRF-funded project in 2018-2019 (Project No. 15163001). In these clinics, potential participants shall be identified by the SC counsellors and referred to our research assistants to proceed with enrolment. In phase 3, the investigators will only recruit ex-smokers from SC clinics, because biochemical verification of both abstinence and habitual tobacco use before quitting in ex-smokers recruited from the community does not exist.
The Q-statements have been developed in our aforementioned pilot study. The Q-sorting process will be conducted on an online platform "easyHTMLQ" (Appendix 2), which is designed for completion of the Q-sorting. In this self-explanatory website, participants can easily drag the statements into the Q-sort grid according to their agreement level, and provide detailed reasons for their choices. Also, the research assistant will communicate with participants online and monitor the Q-sorting process. After the Q-sort process, the results will be documented and exported for further data analysis.
Phase 2 Intervention development (6 months) In phase 2, the investigators shall invite SC counsellors from the above SC clinics to participate in either face-to-face or online project meetings to provide feedback on the intervention protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Outcomes Assessor)
盲法说明
open-labelled RCT
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
- •(for Ex-smoker) :
- •Being a daily smoker before enrolling into the smoking cessation service
- •Not using cigarettes for past 7 days
- •Received at least 4 weeks of smoking cessation service before enrolling into the study
- •Aged 18 years or above
- •No barriers in speaking and listening Cantonese and Mandarin and reading Chinese
排除标准
- •(for Ex-smoker) :
- •Have unstable physical or psychological conditions as advised by doctors or counsellors
- •Have become pregnant in the past two months
- •Inclusion Criteria (for SC counsellors) :
- •SC counsellors from local SC clinics under Tung Wah Group of Hospitals Integrated Center on Smoking Cessation and United Christian Nethersole Community Health Service
研究组 & 干预措施
Intervention group
In the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by the counsellor for 4 weeks.
干预措施: typology-based intervention (Behavioral)
Control Group
In the control group, the routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and they will receive brief e-messages that only consist of general quit advice for 4 weeks.
干预措施: Routine Treatment (Behavioral)
结局指标
主要结局
self-reported abstinence in the past 30 days at 2-month follow-up
时间窗: 2 months
iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence
时间窗: 2 months
Participants who report tobacco abstinence will be invited for a biochemical validation to test if his/her saliva cotinine is less than 30ng/ml measured by the iScreen OFD Cotinine Saliva Test Kit.
the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.
时间窗: 2 months
We will have 4 feasibility questions and 4 appropriateness questions for counsellor to answer from 1 (Completely disagree) to 5 (Completely agree). Also, we will have 4 acceptability questions for ex-smokers to answer. We would like to observe if there is a difference between the intervention group and the control group
次要结局
- Satisfaction about the intervention from SC counsellor(End of all follow-up (approximately 6 month))
- Time required for the counselling(End of all follow-up (approximately 6 month))
- Compliance rate of the SC counsellors in following the intervention protocol(End of all follow-up (approximately 6 month))
- Proportion of screened clients who participate in the RCT(End of all follow-up (approximately 6 month))
- Dropout rate of the participants who consent to the RCT(End of all follow-up (approximately 6 month))
- Satisfaction on the SC counsellors(2 months)
- Satisfaction on the e-messages(2 months)
- Frequency of reading the e-messages(2 months)
- Perceived effectiveness on the intervention(2 months)
- Satisfaction on the enrolment procedures(2 months)
- Intention to recommend the intervention to other smokers(2 months)
- Perceived appropriateness of the intervention length from SC counsellor(End of all follow-up (approximately 6 month))
- Satisfaction on the enrolment and counselling procedures from SC counsellors(End of all follow-up (approximately 6 month))
- Perceived effectiveness of the screening tool from SC counsellor(End of all follow-up (approximately 6 month))
- Perceived clients' acceptance of the intervention from SC counsellor(2 months)
- Intention to apply this intervention in other clients from SC counsellors(End of all follow-up (approximately 6 month))
研究者
Dr. Derek Yee-Tak Cheung
Assistant Professor
The University of Hong Kong