Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong: a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Validated successful smoking reduction rate
研究概览
简要总结
A randomized controlled trial to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong.
详细描述
This is a single blinded randomized controlled trial aiming to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong. This trial consists of a 24-week intervention period. Eligible families will be randomly assigned to either intervention group or control group. Smoking parent(s) in intervention group will be given face-to-face counselling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of NRT and monthly phone follow-up for counselling and support. Smoking parent(s) in control group will be given standard advice and information on smoking cessation.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Research study personnel who will conduct the data collection on outcome measures will be blinded to the group assignment. The researchers who will conduct the data analysis will also be blinded the group assignment.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ethnic Chinese family with children aged younger than 18 years of age.
- •Children who are admitted to the paediatric inpatient units or attend the paediatric specialist clinic at the Prince of Wales Hospital.
- •Children with at least one custodial smoking parent who is living with them.
- •Written informed consent obtained from parents.
排除标准
- •Families not residing in Hong Kong.
- •Children in foster care.
- •Children with unclear custody.
- •Smoking paediatric patients.
- •Presence of smoking household members apart from the parents.
- •Smoking parent who is contraindicated to use nicotine replacement therapy.
研究组 & 干预措施
Intervention
Intervention arm will include face-to-face counseling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of free NRT, referral to quit smoking hotline, monthly phone follow-up and two follow-up visits.
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Validated successful smoking reduction rate
时间窗: Week-24
Urinary cotinine validated parental successful smoking reduction rate at week-24
Self-reported parental successful smoking reduction rate at week-24
时间窗: Week-24
Self-reported reduction of daily cigarette consumption by 50% or more compared with baseline
次要结局
- Urinary cotinine validated parental smoking cessation rate at week-24(Week-24)
- Change in children's urinary cotinine level from baseline to week-24(Week-24)
- Parental self-reported smoking reduction rate of cigarette consumption(Week-24)
- Parental self-reported smoking cessation rate of cigarette consumption(Week-24)
研究者
Kate Ching Ching Chan
Clinical Professional Consultant
Chinese University of Hong Kong