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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group education | Experimental | 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. |
|
| conventional smoking cessation management | Other | The investigators will provide control groups with conventional smoking cessation management, including regular follow-up of smoking status and giving advice of smoking cessation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group education | Behavioral | Group education is one of strategies and behavioural interventions of smoking cessation. Lectures, group meeting for mutual support, discussion of coping skills and suggestions for prevention relapse can help smokers quit smoking by providing support and encouragement from people in same condition. |
| Measure | Description | Time Frame |
|---|---|---|
| change of clinic systolic blood pressure from baseline at the sixth month | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular events (cardiovascular death, stroke,myocardial infarction) | 6 months, 1 year, 2years, 3 years | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiguang Wang, PhD | Contact | +86-21-64370045 | 610911 | jiguangw@163.com |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| conventional smoking cessation management | Behavioral | Including regular follow-up of smoking status and giving advice of smoking cessation |
|
| Hypertension control rate | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years |
| Biochemical smoking cessation rate | CO≤6 ppm | 6 months |
| Self-reported 7-days smoking cessation rate | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years |
| Self-reported long-term smoking cessation rate | Participants hadn't smoked for at least one month. | 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 |
| Relapse rate | 6 month |
| Mini-Mental State Examination score | The cognitive function of participants will be assessed by MMSE. The score of MMSE ranges from 0 (worse) to 30 (better). | 6 months |
| FEV1-Pulmonary functions | Forced expiratory volume in 1 second (FEV1) is the volume of air exhaled in the first second during forced exhalation after maximum inspiration. | 6 months |
| PEF-Pulmonary functions | Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate. | 6 months |
| FVC-Pulmonary functions | Forced vital capacity (FVC), is the maximum amount of air that can be exhaled when blowing out as fast as possible. | 6 months |
| Fagerstrom Test for Nicotine Dependence score | The score of FTND ranges from 0 to 10. Participants with higher scores have higher degree of tobacco dependence and are less likely to maintain the status of smoking cessation. | 6 months |
| Carbon monoxide concentration breathed | 6 months |
| Adverse events, including nicotine withdrawal symptoms and other adverse events. | Nicotine withdrawal symptoms were quantified using the Minnesota Tobacco Withdrawal Scale (MNWS). | 1 month, 2 month, 3 month, 6 month, 1 year, 2 years, 3 years |