Effectiveness of Using Social Networking Service to Prevent Smoking Relapse Among Self-reported Quitters: A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Self Reported Relapse Rate at 2 Months
研究概览
简要总结
According to the Census & Statistics Department, there are still 659,300 daily smokers (11.1%) in Hong Kong. Smoking is addictive, and it is difficult for some motivated smokers to quit without assistance. About 33.2% daily smokers in Hong Kong had tried quitting but they could not maintain abstinence. Relapse prevention is aimed at providing interventions to prevent relapse after starting the abstinence status. This pilot single-blind randomized controlled trial (proof of concept study) will test the effectiveness of social networking services for relapse prevention. The study will first recruit 6 quitters and 6 relapsers for a qualitative interview for the design of intervention. Then, the pilot-RCT trial will recruit 120 participants who have recently quitted smoking, and they will be randomly allocated to 2 intervention groups and one control group. The 2 intervention groups will be arranged to join a WhatsApp or Facebook group for receiving quitting advices from the group moderators and sharing quitting experience with other participants. All participants will receive a self-help booklet of relapse prevention, and will be followed up at 6 weeks, 3 months and 6 months. The primary outcome is the self-report relapse rate (Relapse is tentatively defined as smoking 5 cigarettes in 3 consecutive days since joining the RCT among the 3 study arms.
详细描述
This research project consists of two parts: (1) Formative study on the use of social networking services for relapse prevention; and (2) A RCT to test the effectiveness of social networking services for relapse prevention 7.1 Phase 1 - Formative study 7.1.1 Study design and objectives Literature review and exploratory data analysis on the existing dataset of ICSCs will be conducted to better define smoking relapse and estimate the relapse rate in the natural setting. In addition, an extensive review of the effectiveness of other similar or relevant intervention studies, including our previous studies and preliminary results of using short messaging services at HKU will be conducted. A consultation group formed by the ICSCs and smoking cessation research team of HKU will be responsible to develop the intervention package through the social networking service, including the content of delivered messages, channels, format, time to be sent, intensity, moderator's protocol, manpower and other logistic arrangement. This intervention package will then be tested in some cognitive interview to assess the relevance, appropriateness, potential effectiveness and acceptance level of the SMS.
7.1.2 Selection of subjects We will invite about 6 quitters (without relapsing for at least one month) and 6 relapsers (smoke 5 cigarettes for 3 days after quitting) from the ICSCs by (i) gender (M, F) and (ii) age group (18-39, 40-59, 60+) to comment on the relevance, appropriateness, potential effectiveness and acceptance level of the intervention package.
7.1.3 Procedures for the cognitive interview The sites for conducting the cognitive interview of the intervention package contents will be the eight ICSCs. A face-to-face semi-qualitative interview will be conducted.
7.1.4 Instruments A semi-structured interview guide and instrument will be used to collect their opinions.
7.1.5 Sample size 12 participants (6 quitters and 6 relapsers) will be recruited. Phase 2 - Randomized controlled trial
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoked at least 1 cigarette a day when first joined ICSC
- •Aged 18 or above at the baseline of the RCT
- •Clients who have received 3 to 5 smoking cessation counseling provided by ICSC
- •Reported tobacco abstinence in the past 7 days at the 8-week follow-up since receiving treatment from ICSC
- •Able to communicate in Cantonese and read Chinese
- •Have a local network mobile phone with mobile internet access
排除标准
- •Those with unstable physical or psychological conditions as advised by the doctor or counselor in charge
- •Smokers with diagnosed alcohol dependence by clinicians or the score of the Alcohol Use Disorders Identification Test (AUDIT) is 8 or higher
结局指标
主要结局
Self Reported Relapse Rate at 2 Months
时间窗: 2 months after joining the groups for the social networking services.
Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 2 months.
Self Reported Relapse Rate at 6 Months
时间窗: 6-months
Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 6 months.
次要结局
- Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 2 Months(2 months)
- Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 6 Months(6 months)