Group Education Helps Smoking Cessation and Hypertension Control

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Smoking Cessation, Hypertension

Intervention / Treatment
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* Behavioral: group education
* Behavioral: conventional smoking cessation management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group education<br>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. | Behavioral: group education<br>* 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.<br>|
| Other: conventional smoking cessation management<br>The investigators will provide control groups with conventional smoking cessation management, including regular follow-up of smoking status and giving advice of smoking cessation. | Behavioral: conventional smoking cessation management<br>* Including regular follow-up of smoking status and giving advice of smoking cessation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of clinic systolic blood pressure from baseline at the sixth month |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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group education, smoking cessation, blood pressure