A Cluster Randomized Trial to Evaluate the Effect of Group Education on Smoking Cessation and Blood Pressure in Smoking Elderly Males With Stage 1 and 2 Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- change of clinic systolic blood pressure from baseline at the sixth month
研究概览
简要总结
Smoking elderly males with stage 1 and 2 hypertension who currently smoked at least one cigarette per day and were willing to quit smoke will be invited to this cluster randomized, controlled, interventional, open clinical trial. The investigators will provide participants with group education of smoking cessation and their blood pressure measured at clinic at the sixth month is the primary endpoint. The investigators aim to explore how group education of smoking cessation effects smoking cessation, hypertension control and cardiovascular events.
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
- None
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •signed the informed consent
- •aged 65 to 84
- •new-onset hypertension or poorly controlled hypertension (140mmHg≤systolic blood pressure<180mmHg and (or) 90mmHg≤ diastolic blood pressure<110mmHg)
- •smoked last week and smoked more than 1 cigarette per day on average
- •be willing to quit smoking
- •can communicate normally and cooperate in blood pressure measurements, finishing questionnaires
- •complete interventions and follow-up consistently
排除标准
- •home systolic blood pressure<130mmHg and (or) home diastolic blood pressure<80 mmHg
- •severe communication difficulties (aphasia, hearing impairment, etc.)
- •suffering from mental disorders such as anxiety and depression
- •cancer confirmed
- •with previous serious cardiovascular events such as acute coronary syndrome, acute left heart failure, stroke or with specific cardiovascular therapeutic device such as pacemakers
- •other serious physical illness or illness identified by investigators that unable to participant in study
- •using specific non-permitted medication currently
研究组 & 干预措施
group education
The investigators will provide experimental groups with group education of smoking cessation, including lectures in groups of 50 to 100 people and panel discussion in groups of 5 to 10 people.
干预措施: group education (Behavioral)
conventional smoking cessation management
The investigators will provide control groups with conventional smoking cessation management, including regular follow-up of smoking status and giving advice of smoking cessation.
干预措施: conventional smoking cessation management (Behavioral)
结局指标
主要结局
change of clinic systolic blood pressure from baseline at the sixth month
时间窗: 6 months
次要结局
- change of clinical blood pressure and home blood pressure from baseline(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- Self-reported long-term smoking cessation rate(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- Carbon monoxide concentration breathed(6 months)
- Cardiovascular events (cardiovascular death, stroke,myocardial infarction)(6 months, 1 year, 2years, 3 years)
- Hypertension control rate(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- Self-reported average number of cigarettes smoked per day(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- PEF-Pulmonary functions(6 months)
- FVC-Pulmonary functions(6 months)
- Fagerstrom Test for Nicotine Dependence score(6 months)
- FEV1-Pulmonary functions(6 months)
- Biochemical smoking cessation rate(6 months)
- Self-reported 7-days smoking cessation rate(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
- Relapse rate(6 month)
- Mini-Mental State Examination score(6 months)
- Adverse events, including nicotine withdrawal symptoms and other adverse events.(1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years)
研究者
Ji-Guang Wang
Director of the Shanghai Institute of Hypertension and the Department of Hypertension
Shanghai Jiao Tong University School of Medicine